HomeNDC LookupIngredientsIbuprofen › 70000-0239-01
Leader Ibuprofen 100 mg Tablet, Chewable, 24-count — NDC 70000-0239-01 package photo

Leader Ibuprofen 100 mg Tablet, Chewable, 24-count

by Cardinal Health 110, LLC. dba Leader · 1 BOTTLE in 1 CARTON (70000-0239-1) / 24 TABLET, CHEWABLE in 1 BOTTLE
NDC 70000-0239-01
🏷️ FDA NDC (as labeled) 70000-0239-1 billing pads the package segment with a zero
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) 70000-0239-1
Product NDC 70000-0239
11-digit billing NDC 70000023901
NCPDP billing unit EA — each (per item)
RxCUI 310963
UNII WK2XYI10QM
Application # ANDA076359
SPL Set ID 5975c324-2906-4e71-9b88-2e772d9fbfde
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 2017-04-21
Route ORAL
Dosage form TABLET, CHEWABLE
Substance IBUPROFEN
GPI-14 66100020000520
GPI class Ibuprofen Junior Strength
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 IBUPROFEN JR STR 100 MG TB CHW
FDB brand name Ibuprofen
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0239-1 — a 5-4-1 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 package segment → 70000-0239-01. 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

LabelerCardinal Health 110, LLC. dba Leader
Application holderL PERRIGO CO
FDA applicationANDA076359 (ANDA)
Labeler code70000
First marketedApr 2017
Product typeHuman Otc Drug
Portfolio163 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 JR STR 100 MG TB CHW 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?
📖 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.

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.

💊 What it looks like

Color Purple
ShapeRound
ImprintL521
Size12 mm
ScoringScored — splits in 2
FlavorGrape
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 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • 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 ZK64F7XSTX
    A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • 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.

14 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, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, 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 DailyMedingredient 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.153 $3.66 / 24 tablets
Medicaid paysCMS SDUD · 12 mo $0.2512 $6.03 / 24 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.155 $0.135
▲ Up 13% over the last 24 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
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 mgthis 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 mg 69842-0329-62 CVS 24 tablets Discontinued
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

🏛️
2017
On the market since
Apr 2017
📍
2026
Currently FDA-listed
9 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 70000-0239-01, 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 – Q1 2026 · 5 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
1.3K
Units reimbursed last 4 qtrs
68.6K
Gross reimbursed last 4 qtrs
$17.2K
Avg / prescription
$13.10
Avg / unit
$0.2512
Latest quarter Q1 2026
370Rx
Medicaid pays / ea
$0.2512
gross reimbursed
vs
NADAC / ea
$0.1526
acquisition cost
=
Spread
+$0.0986
+65% vs cost
What Medicaid paid per ea (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
25% FFS 75% MCO
Fee-for-service · 331 Rx Managed care · 985 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 2,460 units · 31.5 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,340 units · 75.6 per 100k residents MN Wisconsin: no data reported WI Michigan: 3,805 units · 37.9 per 100k residents 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: 558 units · 8.1 per 100k residents IN Ohio: 9,846 units · 83.5 per 100k residents OH Pennsylvania: 6,260 units · 48.3 per 100k residents PA New Jersey: 2,239 units · 24.1 per 100k residents NJ Massachusetts: 886 units · 12.7 per 100k residents MA California: 14,250 units · 36.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 1,882 units · 95.1 per 100k residents NE Missouri: 1,761 units · 28.4 per 100k residents MO Kentucky: 13,113 units · 290 per 100k residents KY West Virginia: 1,176 units · 66.4 per 100k residents WV Virginia: no data reported VA Maryland: 3,214 units · 52.0 per 100k residents MD Connecticut: 493 units · 13.6 per 100k residents CT Rhode Island: no data reported RI Arizona: 794 units · 10.7 per 100k residents AZ New Mexico: 1,152 units · 54.5 per 100k residents 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: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 419 units · 61.7 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
8.1290
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 Kentucky 290 /100k
2 Nebraska 95.1 /100k
3 Ohio 83.5 /100k
4 Minnesota 75.6 /100k
5 West Virginia 66.4 /100k
6 D.C. 61.7 /100k
7 New Mexico 54.5 /100k
8 Maryland 52.0 /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.

📊 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 Leader Ibuprofen (this brand).

Top reported reactions

Pain15,065
Fatigue14,475
Nausea13,506
Headache12,087
Arthralgia10,924
Dyspnoea10,531
Vomiting9,975

Age at onset

Neonate574
Infant287
Child1,271
Adolescent1,335
Adult21,461
Elderly7,050

Reporter sex

198,311 reports
Male · 35%
Female · 64%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 15,246 6,173
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 Marketing startStatus
70000-0239-01 You're viewing this 1 BOTTLE in 1 CARTON (70000-0239-1) / 24 TABLET, CHEWABLE in 1 BOTTLE 2017-04-21 Active

📄 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 22 words

Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

⏱️ Dosage and Administration 94 words

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 ~2 min read

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)

📦 Storage and Handling 32 words

Other information • phenylketonurics: contains phenylalanine 6 mg per tablet • store between 20-25 ° C (68-77 ° F) • do not use if printed seal under cap is broken or missing

🧪 Active Ingredient 13 words

Active ingredient (in each chewable tablet) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 40 words

Inactive ingredients acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

🎯 Purpose 4 words

Purposes Pain reliever/fever reducer

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.