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(from DailyMed)

Ibuprofen 100 mg/5mL Suspension, 473 mL

by Strides Pharma Science Limited · 473 mL in 1 BOTTLE (64380-997-04)
NDC 64380-0997-04
🏷️ FDA NDC (as labeled) 64380-997-04 billing pads the product segment with a zero
This package
Contains473 mL Cost per mL$0.0243 NADAC Per package$11.49 / 473 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0426/unit · Part D plans $0.0500/unit — full pricing hub ↓
Also comes in: 118 mL 64380-0997-03
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Ibuprofen (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026
Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0646-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 64380-997-04
Product NDC 64380-997
11-digit billing NDC 64380099704
NCPDP billing unit ML — per mL (volume)
RxCUI 197803
UNII WK2XYI10QM
UPC 0364380997047, 0364380997030
Application # ANDA215311
SPL Set ID 38ebacc3-378f-483e-babc-76119677e7df
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-19
Route ORAL
Dosage form SUSPENSION
Substance IBUPROFEN
GCN Seq No 012080
GCN 35930
HICL code 003723
Ingredient (HICL) Ibuprofen
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2B
Therapeutic class — specific (HIC3) Nsaids, Cyclooxygenase Inhibitor Type Analgesics
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name IBUPROFEN 100 MG/5 ML SUSP
FDB brand name Ibuprofen
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 64380-997-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64380-0997-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerStrides Pharma Science Limited
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA215311 (ANDA)
Labeler code64380
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio195 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IBUPROFEN 100 MG/5 ML SUSP Ingredient Ibuprofen
📗 Our plain-language guide HelloPharmacist
  • It does a lot more than just kill pain. Ibuprofen is an anti-inflammatory drug, so it relieves pain, reduces swelling and inflammation, and brings down fever. Over-the-counter prod...
  • What's ibuprofen actually used for — is it just a painkiller?
  • Yes, it really does help. Ibuprofen can irritate the stomach lining, so taking it with food or a glass of milk significantly reduces the chance of nausea or stomach upset. You don'...
  • Should I take ibuprofen with food? Does it really matter?
📖 Read our full Ibuprofen guide →
1
Nutrient depletion considerations

Ibuprofen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ibuprofen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.024 $11.49 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0426 $20.15 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.0500 $23.65 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2024 Jan 2026 Apr 2026 Aug 2026 $0.026 $0.023
▲ Up 5% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen 100 mg/5mL 51672-2130-01 Sun 1 bottle $0.024 — FDA listed save 2%
Ibuprofen 100 mg/5mL 00904-5309-09 Major 1 bottle $0.024 — Availability likely save 1%
Ibuprofen 100 mg/5mL 00472-2002-16 Actavis 473 ml $0.024 AB Availability likely —
Ibuprofen 100 mg/5mLthis 64380-0997-04 Strides 473 ml $0.024 AB Availability likely —
good sense ibuprofen childrens 100 mg/5mL 00113-0166-26 L. 1 bottle $0.030 — Availability likely +22%
Good Sense Ibuprofen Childrens 100 mg/5mL 00113-0660-26 L. 1 bottle $0.030 — Availability likely +22%
Good Sense Ibuprofen 100 mg/5mL 00113-0685-26 L. 1 bottle $0.030 — Availability likely +22%
good sense ibuprofen childrens 100 mg/5mL 00113-0897-26 L. 1 bottle $0.030 — Availability likely +22%
Ibuprofen Childrens 100 mg/5mL 00904-5577-20 Major 1 bottle $0.030 — Availability likely +22%
Good Neighbor Pharmacy ibuprofen childrens 100 mg/5mL 24385-0009-26 Amerisource 1 bottle $0.030 — Availability likely +22%
Good Neighbor Pharmacy Childrens Ibuprofen 100 mg/5mL 24385-0372-26 Amerisource 1 bottle $0.030 — Availability likely +22%
good neighbor pharmacy ibuprofen 100 mg/5mL 24385-0905-26 Amerisource 1 bottle $0.030 — Availability likely +22%
Childrens Ibuprofen 100 mg/5mL 68001-0521-92 BluePoint 1 bottle $0.030 — Availability likely +22%
Leader Childrens Ibuprofen 100 mg/5mL 70000-0181-01 Cardinal 1 bottle $0.030 — Availability likely +22%
Leader Ibuprofen 100 mg/5mL 70000-0262-01 Cardinal 1 bottle $0.030 — Availability likely +22%
Leader Childrens Ibuprofen 100 mg/5mL 70000-0263-01 Cardinal 1 bottle $0.030 — Availability likely +22%
leader Ibuprofen 100 mg/5mL 70000-0264-01 Cardinal 1 bottle $0.030 — Availability likely +22%
Childrens Ibuprofen 100 mg/5mL 83324-0012-04 Chain 1 bottle $0.030 — Availability likely +22%
Childrens Ibuprofen 100 mg/5mL 83324-0013-04 Chain 1 bottle $0.030 — Availability likely +22%
Childrens Ibuprofen 100 mg/5mL 83324-0014-04 Chain 1 bottle $0.030 — Availability likely +22%
Ibuprofen 100 mg/5mL 51672-1385-08 Sun 1 bottle $0.032 AB Availability likely +33%
Childrens Ibuprofen 100 mg/5mL 45802-0133-26 Padagis 1 bottle $0.034 — Availability likely +39%
Childrens Ibuprofen 100 mg/5mL 45802-0140-26 Padagis 1 bottle $0.034 — Availability likely +39%
ibuprofen 100 mg/5mL 45802-0897-26 Padagis 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 69230-0308-11 Camber 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 69230-0309-11 Camber 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 69230-0310-11 Camber 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 69230-0311-11 Camber 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 70677-0153-01 Strategic 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 70677-1115-01 Strategic 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 70677-1116-01 Strategic 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 70677-1117-01 Strategic 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 70677-1118-01 Strategic 1 bottle $0.034 — Availability likely +39%
Childrens Ibuprofen Oral Suspension Original Berry Flavor 100 mg/5mL 83474-0002-04 Puro 1 bottle $0.034 — Availability likely +39%
Ibuprofen Oral 100 mg/5mL 70677-0150-01 Strategic 1 bottle $0.035 — Availability likely +45%
Ibuprofen Oral 100 mg/5mL 70677-0152-01 Strategic 1 bottle $0.035 — Availability likely +45%
Ibuprofen Oral 100 mg/5mL 70677-0151-01 Strategic 1 bottle $0.035 — Availability likely +45%
Ibuprofen 100 mg/5mL 51672-1409-08 Sun 1 bottle $0.039 AB FDA listed +60%
Ibuprofen 100 mg/5mL 45802-0952-26 Padagis 1 bottle $0.045 AB Availability likely +85%
Ibuprofen 100 mg/5mL 59651-0032-12 Aurobindo 1 bottle $0.045 AB Availability likely +85%
Childrens Ibuprofen Oral Suspension 100 mg/5mL 00121-0833-00 PAI 10 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 00121-0914-00 Pharmaceutical 10 cups — — FDA listed —
Dye Free Childrens Ibuprofen 100 mg/5mL 00121-1022-05 PAI 10 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension 200 mg/10mL 00121-1666-00 PAI 10 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/10mL 00121-1828-00 Pharmaceutical 10 cups — — FDA listed —
Dye Free Childrens Ibuprofen 200 mg/10mL 00121-2044-00 PAI 10 cups — — FDA listed —
ibuprofen childrens 100 mg/5mL 00363-0166-26 Walgreen 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 00363-0660-26 Walgreen 1 bottle — — FDA listed —
Childrens Ibuprofen 100 Dye Free 100 mg/5mL 00363-0806-26 Walgreen 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 00363-0897-26 Walgreen 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 00363-8901-24 WALGREEN 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0170-01 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0171-03 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0207-30 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0232-30 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0290-01 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-1174-12 Haleon 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 10202-0150-24 7-Eleven 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 10202-0711-24 7-Eleven 1 bottle — — FDA listed —
Up and Up childrens ibuprofen 100 mg/5mL 11673-0166-26 Target 1 bottle — — Discontinued —
up and up childrens ibuprofen 100 mg/5mL 11673-0660-26 Target 1 bottle — — FDA listed —
up and up ibuprofen 100 mg/5mL 11673-0685-26 Target 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 11822-0166-01 Rite 1 bottle — — Discontinued —
ibuprofen 100 mg/5mL 11822-0660-01 Rite 1 bottle — — Discontinued —
ibuprofen childrens 100 mg/5mL 11822-0897-01 Rite 1 bottle — — Discontinued —
childrens ibuprofen 100 mg/5mL 11822-1685-00 Rite 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 11822-9998-08 Rite 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 17856-5309-01 ATLANTIC 5 ml — — FDA listed —
Ibuprofen 100 mg/5mL 17856-5310-01 ATLANTIC 50 cups — — FDA listed —
signature care childrens ibuprofen 100 mg/5mL 21130-0011-26 Safeway 1 bottle — — Discontinued —
Signature Care Childrens Ibuprofen 100 mg/5mL 21130-0035-26 Safeway 1 bottle — — Discontinued —
Childrens Ibuprofen 100 mg/5mL 21130-0216-20 Better 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 21130-0506-26 Safeway 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 21130-0510-26 Safeway 1 bottle — — FDA listed —
signature care childrens ibuprofen 100 mg/5mL 21130-0911-26 Safeway 1 bottle — — Discontinued —
Good Neighbor Pharmacy Childrens Ibuprofen 100 mg/5mL 24385-0361-25 Amerisource 1 bottle — — Discontinued —
Childrens FLANAX ORAL 100 mg/5mL 27854-0777-99 Belmora 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 30142-0281-08 KROGER 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 30142-0660-26 Kroger 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 30142-0897-34 Kroger 1 bottle — — Discontinued —
Childrens Ibuprofen 100 mg/5mL 30142-0965-08 Kroger 1 bottle — — FDA listed —
topcare childrens ibuprofen 100 mg/5mL 36800-0166-26 Topco 1 bottle — — FDA listed —
Topcare Childrens Ibuprofen 100 mg/5mL 36800-0660-00 Topco 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 37808-0023-26 H 1 bottle — — FDA listed —
childrens ibuprofen 100 mg/5mL 37808-0200-26 H 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 37808-0363-26 H 1 bottle — — FDA listed —
Equaline ibuprofen childrens 100 mg/5mL 41163-0166-26 United 1 bottle — — FDA listed —
Equaline Ibuprofen 100 mg/5mL 41163-0685-26 United 1 bottle — — FDA listed —
equaline ibuprofen childrens 100 mg/5mL 41163-0897-26 United 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 41250-0419-26 Meijer 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 41250-0660-26 Meijer 1 bottle — — FDA listed —
childrens ibuprofen 100 mg/5mL 41250-0685-26 Meijer 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 41250-0897-26 Meijer 1 bottle — — FDA listed —
care one ibuprofen childrens 100 mg/5mL 41520-0166-26 American 1 bottle — — FDA listed —
Care One ibuprofen childrens 100 mg/5mL 41520-0685-26 American 1 bottle — — FDA listed —
care one ibuprofen 100 mg/5mL 41520-0897-26 American 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 42507-0166-18 HyVee 1 bottle — — FDA listed —
Ibuprofen childrens 100 mg/5mL 42507-0660-26 HyVee 1 bottle — — FDA listed —
childrens ibuprofen 100 mg/5mL 42507-0685-26 HyVee 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 42507-0897-26 HyVee 1 bottle — — FDA listed —
equate ibuprofen childrens 100 mg/5mL 49035-0166-26 Wal-Mart 1 bottle — — FDA listed —
equate ibuprofen childrens 100 mg/5mL 49035-0660-26 Wal-Mart 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 49035-0693-08 EQUATE 1 bottle — — FDA listed —
equate ibuprofen 100 mg/5mL 49035-0897-26 Wal-Mart 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 50090-4129-00 A-S 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 50090-7274-00 A-S 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 50090-7653-00 A-S 1 bottle — — FDA listed —
Childrens Motrin 100 mg/5mL 50580-0184-01 Kenvue 1 bottle — — FDA listed —
Childrens MOTRIN 100 mg/5mL 50580-0601-08 Kenvue 1 bottle — — FDA listed —
Childrens Motrin 100 mg/5mL 50580-0603-04 Kenvue 1 bottle — — FDA listed —
Childrens Motrin 100 mg/5mL 50580-0604-04 Kenvue 1 bottle — — FDA listed —
Dye Free Childrens Ibuprofen 100 mg/5mL 51316-0914-03 CVS 1 bottle — — FDA listed —
Childrens Ibuprofen Bubblegum Dye Free 100 mg/5mL 51316-0932-04 CVS 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 51672-2144-01 Sun 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 51672-5321-01 Sun 1 bottle — — FDA listed —
Pediacare Childrens Ibuprofen Berry 100 mg/5mL 52412-0910-04 RANDOB 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 52412-0911-04 Randob 1 bottle — — FDA listed —
Childrens Ibuprofen bubblegum 100 mg/5mL 53041-0572-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen fruit 100 mg/5mL 53041-0632-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 53041-0634-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen blue raspberry 100 mg/5mL 53041-0638-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen grape 100 mg/5mL 53041-0639-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 53942-0119-24 DEMOULAS 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 53943-0119-24 Discount 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 53943-0682-03 Discount 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 55154-1577-05 Cardinal 5 cups — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 55319-0114-03 Family 1 bottle — — FDA listed —
Childrens Ibuprofen 572 100 mg/5mL 55319-0929-03 Family 1 bottle — — FDA listed —
dg health childrens ibuprofen 100 mg/5mL 55910-0102-26 Dolgencorp, 1 bottle — — FDA listed —
DG Health childrens ibuprofen 100 mg/5mL 55910-0166-26 Dolgencorp, 1 bottle — — FDA listed —
Rexall Ibuprofen 100 mg/5mL 55910-0685-26 Dolgencorp, 1 bottle — — FDA listed —
DG Health Ibuprofen 100 mg/5mL 55910-0897-26 Dolgencorp 1 bottle — — FDA listed —
profen ib 100 mg/5mL 56062-0166-26 Publix 1 bottle — — FDA listed —
profen IB childrens 100 mg/5mL 56062-0897-26 Publix 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 58602-0002-20 Aurohealth 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 58602-0003-20 Aurohealth 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 58602-0008-24 Aurohealth 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 59779-0166-26 CVS 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 59779-0660-26 CVS 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 59779-0685-26 CVS 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 59779-0897-26 CVS 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 59779-0971-26 CVS 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 60687-0743-17 American 10 cups — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8540-01 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8851-01 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8852-01 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8853-01 Bryant 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 63868-0796-04 Chain 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension, Bubble Gum 100 mg/5mL 63941-0127-24 Best 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension, Dye Free 100 mg/5mL 63941-0128-24 Best 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 68071-1628-04 NuCare 118 ml — — FDA listed —
Ibuprofen 100 mg/5mL 68071-3589-04 NuCare 1 bottle — AB FDA listed —
Childrens Ibuprofen 100 mg/5mL 68071-5290-04 NuCare 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 68094-0494-61 Precision 10 cups — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 68094-0503-61 Precision 10 cups — — Discontinued —
Dye Free Childrens Ibuprofen 100 mg/5mL 68094-0600-61 Precision 10 cups — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 68788-4031-01 Preferred 1 bottle — — FDA listed —
good sense ibuprofen childrens 100 mg/5mL 68788-4036-01 Preferred 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 68788-8288-01 Preferred 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 68998-0320-24 Marc 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 69256-0634-03 Harris 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 69618-0078-54 Reliable 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 70518-4595-00 REMEDYREPACK 1 bottle — AB FDA listed —
Ibuprofen 100 mg/5mL 71205-0213-72 Proficient 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 71205-0367-72 Proficient 1 bottle — AB FDA listed —
ibuprofen 100 mg/5mL 71205-0395-72 Proficient 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 71205-0716-72 Proficient 1 bottle — AB FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1909-02 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1910-02 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1911-02 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1912-02 Bryant 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72162-2285-02 Bryant 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72162-2286-02 Bryant 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 72162-2341-02 Bryant 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0166-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0660-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0685-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0897-26 Amazon.com 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72888-0479-01 Advagen 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 76281-0119-24 AptaPharma 1 bottle — — FDA listed —
Childrens Ibuprofen Grape 100 mg/5mL 76281-0126-24 AptaPharma 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension Dye free 100 mg/5mL 76281-0128-24 AptaPharma 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 79395-0003-92 Chalkboard 1 bottle — — FDA listed —
CHILDRENS Ibuprofen 100 mg/5mL 81033-0019-01 Kesin 100 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension Dye Free 100 mg/5mL 81522-0311-11 FSA 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 81522-0700-04 FSA 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 81522-0938-04 FSA 1 bottle — — Discontinued —
Kosher Meds 100 mg/5mL 82179-0001-04 Mollec 1 bottle — — FDA listed —
Kosher Meds Dye-Free Ibuprofen 100 mg/5mL 82179-0006-04 Mollec 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 63941-0761-94 Best 1 bottle — — Discontinued —
Ibuprofen Childrens 100 mg/5mL 63941-0762-94 Best 1 bottle — — Discontinued —
Ibuprofen Childrens 100 mg/5mL 63941-0760-94 Best 1 bottle — — Discontinued —
Ibuprofen 100 mg/5mL 51662-1582-01 HF 120 ml — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72288-0392-34 Amazon.com 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 68071-5315-04 NuCare 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64380-0997-04, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
891
Units reimbursed last 4 qtrs
168.8K
Gross reimbursed last 4 qtrs
$7.2K
Avg / prescription
$8.07
Avg / unit
$0.0426
Latest quarter Q4 2025
23Rx
Medicaid pays / mL
$0.0426
gross reimbursed
vs
NADAC / mL
$0.0243
acquisition cost
=
Spread
+$0.0183
+75% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
91% MCO
Fee-for-service · 82 Rx Managed care · 809 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,576 units · 43.6 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 1,740 units · 14.8 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 133,722 units · 1,439 per 100k residents NJ Massachusetts: no data reported MA California: 10,060 units · 25.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,214 units · 26.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,305 units · 72.3 per 100k residents LA Mississippi: no data reported MS Alabama: 2,616 units · 51.2 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 13,541 units · 44.4 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
14.81,439
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 1,439 /100k
2 Louisiana 72.3 /100k
3 Alabama 51.2 /100k
4 Texas 44.4 /100k
5 Wisconsin 43.6 /100k
6 Kentucky 26.8 /100k
7 California 25.8 /100k
8 Ohio 14.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml this page64380-0997-04 891 Rx · $7,189
1 bottle64380-0997-03 23 Rx · $222
Drug total (last 4 qtrs): 914 Rx · 173,604 units · $7,411 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ibuprofen — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ibuprofen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.28M
Claims incl. refills
1.8M
Beneficiaries
1.4M
Spend / beneficiary
$8.95
Spend / claim
$6.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ibuprofen — the ingredient across all brands.

Top reported reactions

Pain19,495
Fatigue18,755
Nausea18,290
Headache16,566
Arthralgia13,469
Dyspnoea13,139
Vomiting13,046

Age at onset

Neonate657
Infant880
Child2,279
Adolescent1,596
Adult26,531
Elderly8,944

Reporter sex

283,500 reports
Male · 34%
Female · 65%
Unknown · 1%

Serious outcomes

Hospitalization85,488
Death18,734
Life-threatening14,904
Disabling11,119
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 21,295 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
64380-0997-03 1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE $0.0324 / mL $3.82 2023-09-19 Active
64380-0997-04 You're viewing this 473 mL in 1 BOTTLE (64380-997-04) $0.0243 / mL $11.49 2023-09-19 Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0243 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 64380-0997-04?
NDC 64380-0997-04 contains 473 mL — 473 ml in 1 bottle.
What NDC number is used to bill for this package of Ibuprofen 100 mg/5mL Suspension?
Bill NDC 64380-0997-04 — the 11-digit billing format is 64380099704. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 116 words ▾

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). Ibuprofen oral suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ).

Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ).

🎯 Indications and Usage 153 words ▾

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients, ibuprofen oral suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age.

For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults, ibuprofen oral suspension is indicated: For treatment of primary dysmenorrhea.

For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended. (See PRECAUTIONS – Drug Interactions ).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with ibuprofen oral suspension, the dose and frequency should be adjusted to suit an individual patient's needs.

Pediatric Patients Fever Reduction: For reduction of fever in children, 6 months up to 2 years of age, the dosage should be adjusted on the basis of the initial temperature level (see CLINICAL PHARMACOLOGY ). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5 0 F, or 10 mg/kg if the baseline temperature is 102.5 0 F or greater. The duration of fever reduction is generally 6 to 8 hours.

The recommended maximum daily dose is 40 mg/kg. Analgesia: For relief of mild to moderate pain in children 6 months up to 2 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg.

Doses should be given so as not to disturb the child's sleep pattern. Juvenile Arthritis: The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage ). Patients with milder disease may be adequately treated with 20 mg/kg/day.

In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clinical effect is obtained, the dosage should be lowered to the smallest dose of ibuprofen oral suspension needed to maintain adequate control of symptoms.

Pediatric patients receiving doses above 30 mg/kg/day or if abnormal liver function tests have occurred with previous NSAID treatments should be carefully followed for signs and symptoms of early liver dysfunction. Adults Primary Dysmenorrhea: For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen oral suspension should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain. Rheumatoid Arthritis and Osteoarthritis: Suggested dosage: 1200 to 3200 mg daily (300 mg q.i.d. or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d.).

Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. Individualization of Dosage: The dose of ibuprofen oral suspension should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

One fever study showed that, after the initial dose of ibuprofen oral suspension, subsequent doses may be lowered and still provide adequate fever control. In a situation when low fever would require the ibuprofen oral suspension 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen. In chronic conditions, a therapeutic response to ibuprofen oral suspension therapy is sometimes seen in a few days to a week, but most often is observed by two weeks.

After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required. Patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of ibuprofen oral suspension that yields acceptable control should be employed.

Ibuprofen oral suspension may be used…

⛔ Contraindications 78 words ▾

CONTRAINDICATIONS Ibuprofen oral suspension is contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen oral suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDS have been reported in such patients (see WARNINGS – Anaphylactoid Reactions, and PRECAUTIONS – Preexisting Asthma ).

Ibuprofen oral suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

⚠️ Warnings ~3 min read ▾

WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as ibuprofen, increases the risk of serious gastrointestinal (GI) events (see WARNINGS ). Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS ). Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of ibuprofen oral suspension in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ibuprofen oral suspension is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Hypertension NSAIDs, including ibuprofen oral suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen oral suspension, should be used with caution in patients with hypertension.

Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID 'Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately 2-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for hea…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus.

Additional adverse experiences reported occasionally include: Body as a whole - fever, infection, sepsis Cardiovascular system - congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope Digestive system - dry mouth, duodenitits, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding Hemic and lymphatic system - ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo Respiratory system - asthma, dyspnea Skin and appendages - alopecia, photosensitivity, sweat Special senses - blurred vision Urogenital system - cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactions, which occur rarely are: Body as a whole - anaphylactic reactions, anaphylactoid reactions, appetite changes Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis Digestive system - eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis Hemic and lymphatic system - agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsions, coma, emotional lability, hallucinations, aseptic meningitis Respiratory - apnea, respiratory depression, pneumonia, rhinitis Skin and appendages - angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, fixed drug eruption (FDE), urticaria, vesiculobullous eruptions Special senses - amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment Urogenital - azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions ~2 min read ▾

Drug Interactions ACE-Inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Aspirin Pharmacodynamic studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with entericcoated low-dose aspirin.

The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a once-daily regimen of ibuprofen; however, this finding cannot be extended to entericcoated low-dose aspirin (see CLINICAL PHARMACOLOGY-Pharmacodynamics ). Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking low-dose aspirin for cardioprotection who require analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics, where appropriate.

As with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics Clinical studies, as well as post marketing observations, have shown that ibuprofen oral suspension can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects ), as well as to assure diuretic efficacy. Lithium Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.

This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.) Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.

This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin Several short-term controlled studies failed to show that ibuprofen significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on warfarin-type anticoagulants.

However, because bleeding has been reported when ibuprofen and other NSAIDs have been administered to patients on warfarin-type anticoagulants, the physician should be cautious when administering ibuprofen to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

🤰 Pregnancy ~3 min read ▾

Pregnancy Risk Summary Use of NSAIDs, including ibuprofen oral suspension, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ibuprofen oral suspension use between about 20 and 30 weeks of gestation, and avoid ibuprofen oral suspension use at about 30 weeks of gestation and later in pregnancy (see WARNINGS; Fetal Toxicity ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ibuprofen oral suspension, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryo fetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Animal reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ibuprofen oral suspension, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity ).

Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If ibuprofen oral suspension treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue ibuprofen oral suspension and follow up according to clinical practice (see WARNINGS; Fetal Toxicity ).

Data Human Data There are no adequate, well-controlled studies in pregnant women. Ibuprofen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Premature Closure of Fetal Ductus Arteriosus : Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment : Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cess…

🧒 Pediatric Use 51 words ▾

Pediatric Use Safety and effectiveness of ibuprofen oral suspension in pediatric patients below the age of 6 months have not been established (see CLINICAL PHARMACOLOGY - Clinical Studies). Dosing of ibuprofen oral suspension in children 6 months or older should be guided by their body weight (see DOSAGE AND ADMINISTRATION ).

🧓 Geriatric Use 18 words ▾

Geriatric Use As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

🆘 Overdosage ~2 min read ▾

OVERDOSAGE The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness.

Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported.

The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage.

Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen. In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated.

Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility.

Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents. In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity.

The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics - Ibuprofen is a racemic mixture of [-]R-and [+]S-isomers. In vivo and in vitro studies indicate that the [+]S- isomer is responsible for clinical activity. The [-]R-form, while thought to be pharmacologically inactive, is slowly and incompletely (~60%) interconverted into the active [+]S species in adults.

The degree of interconversion in children is unknown, but is thought to be similar. The [-]R-isomer serves as a circulating reservoir to maintain levels of active drug. Ibuprofen is well absorbed orally, with less than 1% being excreted in the urine unchanged.

It has a biphasic elimination time curve with a plasma half-life of approximately 2 hours. Studies in febrile children have established the dose-proportionality of 5 and 10 mg/kg doses of ibuprofen. Studies in adults have established the dose-proportionality of ibuprofen as a single oral dose from 50 to 600 mg for total drug and up to 1200 mg for free drug.

Absorption - In vivo studies indicate that ibuprofen is well absorbed orally from the suspension formulation, with peak plasma levels usually occurring within 1 to 2 hours (see Table 1). Table 1 Pharmacokinetic Parameters of Ibuprofen Oral Suspension [Mean values (% coefficient of variation)] Legend: AUC inf = Area-under-the-curve to infinity T max = Time-to-peak plasma concentration C max = Peak plasma concentration Cl/F = Clearance divided by fraction at drug absorbed Dose 200 mg (2.8 mg/kg) in Adults 10 mg/kg in Febrile Children Formulation Suspension Suspension Number of Patients 24 18 AUC inf (mcg•h/mL) 64 155 (27%) (24%) C max (mcg/mL) 19 55 (22%) (23%) T max (h) 0.79 0.97 (69%) (57%) CI/F (mL/h/kg) 45.6 68.6 (22%) (22%) Antacids - A bioavailability study in adults has shown that there was no interference with the absorption of ibuprofen when given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.

H-2 Antagonists– In studies with human volunteers, coadministration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. Food Effects - Absorption is most rapid when ibuprofen is given under fasting conditions. Administration of ibuprofen oral suspension with food affects the rate but not the extent of absorption.

When taken with food, Tmax is delayed by approximately 30 to 60 minutes, and peak levels are reduced by approximately 30 to 50%. Distribution - Ibuprofen, like most drugs of its class, is highly protein bound (>99% bound at 20 mcg/mL). Protein binding is saturable and at concentrations >20 mcg/mL binding is non-linear.

Based on oral dosing data there is an age- or fever- related change in volume of distribution for ibuprofen. Febrile children <11 years old have a volume of approximately

0.2 L/kg while adults have a volume of approximately

0.12L/kg. The clinical significance of these findings is unknown. Metabolism - Following oral administration, the majority of the dose was recovered in the urine within 24 hours as the hydroxy-(25%) and carboxypropyl-(37%) phenylpropionic acid metabolites.

The percentages of free and conjugated ibuprofen found in the urine were approximately 1% and 14%, respectively. The remainder of the drug was found in the stool as both metabolites and unabsorbed drug. Elimination - Ibuprofen is rapidly metabolized and eliminated in the urine.

The excretion of ibuprofen is virtually complete 24 hours after the last dose. It has a biphasic plasma elimination time curve with a half-life of approximately 2.0 hours. There is no difference in the observed terminal elimination rate or half-life between children and adults, however, there is an age-or fever-related change in total clearance.

This suggests that the observed change in clearance is due to changes in the volume of distribution of ibuprofen (see Table 1 for Cl/F values). Clinical Studies - Controlled clinical trials comparing doses of 5 and 10 mg/kg ibuprofen suspension and 10 to 15 mg/kg of acetamino…

📦 How Supplied / Storage and Handling 87 words ▾

HOW SUPPLIED Ibuprofen Oral Suspension, USP 100 mg/5 mL Pale yellow to orange color suspension with mixed berry flavor -Carton containing bottle of 4 fl oz (118 mL) - NDC 64380-997-03 -Bottles of One Pint (473 mL) – NDC 64380-997-04 Shake well before using. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP. Manufactured by: Strides Pharma Science Limited Bengaluru – 562106, India Distributed by: Strides Pharma Inc.

Bridgewater, NJ 08807 Revised: 09/2025

📋 Description 188 words ▾

DESCRIPTION The active ingredient in Ibuprofen oral suspension, USP 100 mg/5 mL is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white, crystalline powder, with a melting point of 75° to 78°C.

It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid.

The molecular weight of ibuprofen is 206.28. Its molecular formula is C 13 H 18 O 2 and it has the following structural formula: Ibuprofen oral suspension, USP 100 mg/5 mL is a sucrose-sweetened, pale yellow to orange color suspension with mixed berry flavor, containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, glycerin, hypromellose, mix berry flavor (natural and artificial flavor and propylene glycol), polysorbate 80, purified water, sodium benzoate, sucrose and xanthan gum.

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💬 Information for Patients ~2 min read ▾

Information for Patients: Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Cardiovascular Thrombotic Events - Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS ).

Ibuprofen oral suspension, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization or even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation ).

Serious Skin Reactions, including DRESS - Advise patients to stop taking ibuprofen oral suspension immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible (see WARNINGS ). Heart Failure and Edema - Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS ). Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritis, jaundice, right upper quadrant tenderness, and "flu-like" symptoms).

If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS ).

Fetal Toxicity - Inform pregnant women to avoid use of ibuprofen oral suspension and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with ibuprofen oral suspension is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours (see WARNINGS; Fetal Toxicity, PRECAUTIONS; Pregnancy ).

💬 Medication Guide ~3 min read ▾

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDS) What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death . This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs right before or after heart bypass surgery Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant.

Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea more tired or weaker than usual flu-like symptoms vomit blood diarrhea there is blood in your bowel movement or it is black and sticky like tar itching unusual weight gain your skin or eyes look yellow skin rash or blisters with fever indigestion or stomach pain swelling of the arms and legs, hands and feet If you take too much of your NSAID, ca…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.