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CHILDRENS ADVIL

ibuprofen · Suspension

Over-the-counter NDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
CHILDRENS ADVIL
Generic name
ibuprofen
Dosage form
Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
7
Packages
11
Data completeness
83% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibuprofen 100 mg/5mL 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension
Route of administration
Oral
Presentations
18

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020589
Application type
NDA · New Drug Application
Approval date
June 27, 1996
Sponsor
HALEON US HOLDINGS
Products on application
2
Submissions recorded
28
Products approved under application 020589.
Product Trade name Form Strength Ingredient Status TE Flags
020589-001 CHILDREN'S ADVIL SUSPENSION IBUPROFEN Over-the-counter —
020589-002 CHILDREN'S ADVIL-FLAVORED SUSPENSION IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 020589.
Type No. Action Status Date Review
Supplement 44 Labeling Approved June 26, 2026 Standard
Supplement 43 Labeling Approved May 1, 2026 Standard
Supplement 39 Manufacturing (CMC) Approved September 20, 2022 N/A
Supplement 37 Labeling Approved August 30, 2018 Standard
Supplement 35 Labeling Approved June 21, 2017 Standard
Supplement 34 Labeling Approved March 23, 2017 Standard
Supplement 33 Manufacturing (CMC) Approved July 28, 2016 Standard
Supplement 29 Manufacturing (CMC) Approved December 20, 2013 Standard
Supplement 32 Manufacturing (CMC) Approved June 12, 2013 Standard
Supplement 31 Manufacturing (CMC) Approved December 7, 2012 Standard
Supplement 30 Manufacturing (CMC) Approved September 4, 2012 Standard
Supplement 26 Labeling Approved September 2, 2010 Standard
Supplement 24 Labeling Approved May 19, 2009 Standard
Supplement 23 Labeling Approved June 11, 2008 Standard
Supplement 19 Labeling Approved December 7, 2005 Standard
Supplement 17 Labeling Approved March 18, 2005 Standard
Supplement 15 Labeling Approved November 14, 2002 Standard
Supplement 12 Manufacturing (CMC) Approved September 17, 2001 Standard
Supplement 14 Manufacturing (CMC) Approved August 2, 2001 Standard
Supplement 13 Manufacturing (CMC) Approved August 2, 2001 Standard
Supplement 9 Labeling Approved August 25, 2000 Standard
Supplement 11 Manufacturing (CMC) Approved July 14, 2000 Standard
Supplement 10 Manufacturing (CMC) Approved March 30, 2000 Standard
Supplement 8 Manufacturing (CMC) Approved October 17, 1999 Standard
Supplement 6 Manufacturing (CMC) Approved October 14, 1998 Standard
Supplement 4 Manufacturing (CMC) Approved May 5, 1998 Standard
Supplement 1 Manufacturing (CMC) Approved November 7, 1997 Standard
Original application 1 Type 8 - Partial Rx to OTC Switch Approved June 27, 1996 Standard

Review documents

  • 0 · Supplement · June 29, 2026
  • 0 · Supplement · June 29, 2026
  • 0 · Supplement · May 4, 2026
  • 0 · Supplement · September 21, 2022
  • 0 · Supplement · September 21, 2022
  • 0 · Supplement · August 30, 2018
  • 0 · Supplement · June 27, 2017
  • 0 · Supplement · June 22, 2017
  • 0 · Supplement · March 24, 2017
  • 0 · Supplement · March 24, 2017
  • 0 · Supplement · January 13, 2014
  • 0 · Supplement · December 24, 2013
  • 0 · Supplement · September 7, 2010
  • 0 · Supplement · May 26, 2009
  • 0 · Supplement · June 16, 2008
  • 0 · Supplement · December 15, 2005
  • 0 · Supplement · March 23, 2005
  • 0 · Supplement · March 23, 2005
  • 0 · Supplement · April 25, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240208). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240208 HUMAN OTC DRUG · 20240208

Indications and Usage

openFDA Drug Labeling

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

Purpose Fever reducer/Pain reliever

Dosage and Administration

openFDA Drug Labeling

Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise use age. • repeat dose every 6-8 hours , if needed • do not use more than 4 times a day • measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension. Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 5 mL 36-47 lb 4-5 yr 7.5 mL 48-59 lb 6-8 yr 10 mL 60-71 lb 9-10 yr 12.5 mL 72-95 lb 11 yr 15 mL

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 the 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 any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • stomach bleeding warning applies to the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • 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 • 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.

Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if • stomach bleeding warning applies to the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • child is taking a diuretic

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II September 5, 2018 Pfizer Global Supply Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0573-0170-01 0573-0170 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0170-01) / 30 mL in 1 BOTTLE June 27, 1996
0573-0170-30 0573-0170 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0170-30) / 120 mL in 1 BOTTLE June 27, 1996
0573-0170-32 0573-0170 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0170-32) / 120 mL in 1 BOTTLE June 27, 1996
0573-0171-03 0573-0171 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0171-03) / 30 mL in 1 BOTTLE June 27, 1996
0573-0171-30 0573-0171 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0171-30) / 120 mL in 1 BOTTLE June 27, 1996
0573-0171-32 0573-0171 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0573-0171-32) / 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE June 27, 1996
0573-0207-30 0573-0207 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0207-30) / 120 mL in 1 BOTTLE September 4, 2012
0573-0232-30 0573-0232 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0232-30) / 120 mL in 1 BOTTLE December 20, 2013
0573-0290-01 0573-0290 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0290-01) / 30 mL in 1 BOTTLE December 1, 2010
0573-0290-30 0573-0290 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0290-30) / 120 mL in 1 BOTTLE December 1, 2010
0573-1174-12 0573-1174 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-1174-12) / 120 mL in 1 BOTTLE September 30, 2019
0573-0170 0573-0170 Haleon US Holdings LLC — June 27, 1996
0573-0171 0573-0171 Haleon US Holdings LLC — June 27, 1996
0573-0174 0573-0174 Haleon US Holdings LLC — June 27, 1996
0573-0207 0573-0207 Haleon US Holdings LLC — September 4, 2012
0573-0232 0573-0232 Haleon US Holdings LLC — December 20, 2013
0573-0290 0573-0290 Haleon US Holdings LLC — December 1, 2010
0573-1174 0573-1174 Haleon US Holdings LLC — June 27, 1996

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 11 sections on this page.