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CHILDRENS ADVIL
ibuprofen · Suspension
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Ibuprofen | 100 mg/5mL | 310965 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purpose
openFDA Drug LabelingPurpose Fever reducer/Pain reliever
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWARNINGS 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed 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| 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| 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
| 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.