childrens ibuprofen 100 mg Tablet, Chewable
by CVS Pharmacy · 2 BOTTLE in 1 CARTON (69842-329-67) / 24 TABLET, CHEWABLE in 1 BOTTLE
NDC 69842-0329-67
🏷️ FDA NDC (as labeled)
69842-329-67
billing pads the product segment with a zero
This package
Contains24 tablet, chewable in 1 bottle
Pack sizes2 compare ↓
Also comes in:
24 tablets 69842-0329-62
OTC
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 →
⚠️
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)
69842-329-67
Product NDC
69842-329
11-digit billing NDC
69842032967
NCPDP billing unit
EA — each (per item)
RxCUI
310963
UNII
WK2XYI10QM
Application #
ANDA076359
SPL Set ID
6d047655-2b29-4f74-ac6e-93b02c25870c
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
2019-06-11
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
IBUPROFEN
GPI-14
66100020000520
GCN Seq No
022530
GCN
35749
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
CVS IBUPROFEN 100 MG CHEW TAB
FDB brand name
Ibuprofen
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 69842-329-67 — 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 → 69842-0329-67. 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
LabelerCVS Pharmacy
Application holderL PERRIGO CO
FDA applicationANDA076359 (ANDA)
Labeler code69842
First marketedJun 2019
Product typeHuman Otc Drug
Portfolio550 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 CVS IBUPROFEN 100 MG CHEW TAB Ingredient Ibuprofen
📖 What it is MedlinePlus · NLM
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...
Read the full MedlinePlus article ↗📗 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ibuprofen — tap one for details:
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.
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.
💬 Questions about Ibuprofen?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeRound
ImprintL7W6
Size13 mm
ScoringScored — splits in 2
FlavorOrange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 23OV73Q5G9
Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
-
UNII Z0H242BBR1
Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
-
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII 241ATL177A
Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
-
UNII AB6MNQ6J6L
Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesacesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
24 tablets
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Sense Childrens Ibuprofen 100 mg 00113-2461-62 | L. | 24 tablets | $0.153 | — | Availability likely | — |
| Good Neighbor Pharmacy Childrens Ibuprofen 100 mg 46122-0617-62 | Amerisource | 24 tablets | $0.153 | — | Availability likely | — |
| good neighbor pharmacy childrens ibuprofen 100 mg 46122-0632-62 | Amerisource | 24 tablets | $0.153 | — | Availability likely | — |
| Leader Ibuprofen 100 mg 70000-0239-01 | Cardinal | 24 tablets | $0.153 | — | Availability likely | — |
| foster and thrive childrens ibuprofen ib 100 mg 70677-1145-01 | Strategic | 24 tablets | $0.153 | — | Availability likely | — |
| good sense childrens ibuprofen 100 mg 00113-6040-62 | L. | 24 tablets | — | — | FDA listed | — |
| Good Sense Childrens Ibuprofen 100 mg 00113-7366-62 | L. | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 100 mg 00363-1461-62 | Walgreen | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 100 mg 00363-1521-62 | Walgreen | 24 tablets | — | — | FDA listed | — |
| Junior Strength Advil 100 mg 00573-0179-20 | Haleon | 24 tablets | — | — | FDA listed | — |
| Up and Up Childrens Ibuprofen 100 mg 11673-0593-62 | Target | 24 tablets | — | — | FDA listed | — |
| Up and Up Childrens Ibuprofen 100 mg 11673-0741-62 | Target | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 11822-1521-00 | Rite | 24 tablets | — | — | FDA listed | — |
| Childrens Ibuprofen 100 mg 11822-4461-00 | Rite | 24 tablets | — | — | FDA listed | — |
| signature care childrens ibuprofen 100 mg 21130-0701-62 | Safeway | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 21130-0790-62 | Safeway | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 30142-0402-62 | Kroger | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 30142-0513-62 | Kroger | 24 tablets | — | — | FDA listed | — |
| topcare childrens ibuprofen 100 mg 36800-0811-62 | Topco | 24 tablets | — | — | FDA listed | — |
| equaline childrens ibuprofen 100 mg 41163-0710-62 | United | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 41250-0331-62 | Meijer | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 41250-0726-62 | Meijer | 24 tablets | — | — | FDA listed | — |
| careone childrens ibuprofen 100 mg 41520-0633-62 | American | 24 tablets | — | — | FDA listed | — |
| careone childrens ibuprofen 100 mg 41520-0740-62 | American | 24 tablets | — | — | FDA listed | — |
| ibuprofen 100 mg 42507-0461-62 | HyVee | 24 tablets | — | — | FDA listed | — |
| equate ibuprofen 100 mg 49035-0521-62 | Wal-Mart | 24 tablets | — | — | FDA listed | — |
| Childrens Motrin 100 mg 50580-0932-01 | Kenvue | 24 tablets | — | — | FDA listed | — |
| Childrens Motrin 100 mg 50580-0933-01 | Kenvue | 24 tablets | — | — | FDA listed | — |
| rexall ibuprofen 100 mg 55910-0521-62 | Dolgencorp, | 24 tablets | — | — | FDA listed | — |
| Childrens Ibuprofen 100 mg 56062-0801-62 | Publix | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mgthis 69842-0329-67 | CVS | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 69842-0521-62 | CVS | 24 tablets | — | — | FDA listed | — |
| childrens ibuprofen 100 mg 69842-0706-62 | CVS | 24 tablets | — | — | FDA listed | — |
| Junior Strength Advil 100 mg 71205-0425-24 | Proficient | 24 tablets | — | — | FDA listed | — |
| Basic Care Childrens Ibuprofen 100 mg 72288-0461-62 | Amazon.com | 24 tablets | — | — | FDA listed | — |
| basic care childrens ibuprofen 100 mg 72288-0521-62 | Amazon.com | 24 tablets | — | — | FDA listed | — |
| basic care childrens ibuprofen 100 mg 72288-0763-62 | Amazon.com | 24 tablets | — | — | FDA listed | — |
| Childrens Ibuprofen 100 mg 79481-0419-00 | Meijer, | 24 tablets | — | — | FDA listed | — |
| Childrens Ibuprofen 100 mg 72288-0320-62 | Amazon.com | 24 tablets | — | — | 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
🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Ibuprofen (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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 CHILDRENS Ibuprofen (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69842-0329-62 | 1 BOTTLE in 1 CARTON (69842-329-62) / 24 TABLET, CHEWABLE in 1 BOTTLE | 2019-06-11 | Discontinued by firm |
| 69842-0329-67 You're viewing this | 2 BOTTLE in 1 CARTON (69842-329-67) / 24 TABLET, CHEWABLE in 1 BOTTLE | 2019-06-11 | Active |
Pack size FAQ
What quantity is in NDC 69842-0329-67?
NDC 69842-0329-67 is listed by the FDA — 2 bottle in 1 carton / 24 tablet, chewable in 1 bottle.
What NDC number is used to bill for this package of childrens ibuprofen 100 mg Tablet, Chewable?
Bill NDC 69842-0329-67 — the 11-digit billing format is 69842032967. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69842-329-67, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69842-0329-67, written without dashes as 69842032967. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69842-0329-67, the first segment (69842) is the labeler code FDA assigned to CVS Pharmacy; the middle segment (0329) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (67) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CVS Pharmacy. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 24 tablets (69842-0329-62). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CVS Pharmacy is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
⏱️ Dosage and Administration ▾
Directions • chew or crush tablets completely before swallowing • this product does not contain directions or complete warnings for adult use • do not give more than directed • find right dose on chart below. If possible, use weight to dose; otherwise use age. • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3
⚠️ Warnings ▾
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if your child: • has had stomach ulcers or bleeding problems • takes a blood thinning (anticoagulant) or steroid drug • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • takes more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Do not use • if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • stomach bleeding warning applies to your child • child has a history of stomach problems, such as heartburn • child has problems or serious side effects from taking pain relievers or fever reducers • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke • child has asthma • child is taking a diuretic Ask a doctor or pharmacist before use if the child is • under a doctor’s care for any serious condition • taking any other drug When using this product • mouth or throat burning may occur; give with food or water • take with food or milk if stomach upset occurs Stop use and ask a doctor if • child experiences any of the following signs of stomach bleeding: • feels faint • vomits blood • has bloody or black stools • has stomach pain that does not get better • child has symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • the child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
🧪 Active Ingredient ▾
Active ingredient (in each chewable tablet) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
🧪 Inactive Ingredients ▾
Inactive ingredients acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
🎯 Purpose ▾
Purposes Pain reliever/fever reducer
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.