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Childrens Ibuprofen

Ibuprofen · Suspension

Over-the-counter ANDA 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 Ibuprofen
Generic name
Ibuprofen
Dosage form
Suspension
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
36
Packages
46
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
82

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
074937
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 22, 1998
Sponsor
PERRIGO
Products on application
1
Submissions recorded
25
Products approved under application 074937.
Product Trade name Form Strength Ingredient Status TE Flags
074937-001 CHILDREN'S IBUPROFEN SUSPENSION IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 074937.
Type No. Action Status Date Review
Supplement 57 Labeling Approved May 18, 2011 —
Supplement 40 Labeling Approved March 17, 2006 —
Supplement 23 Manufacturing (CMC) Approved November 26, 2002 —
Supplement 22 Manufacturing (CMC) Approved November 26, 2002 —
Supplement 24 Labeling Approved August 2, 2002 —
Supplement 20 Manufacturing (CMC) Approved August 21, 2001 —
Supplement 21 Labeling Approved August 3, 2001 —
Supplement 19 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 18 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 17 Labeling Approved July 30, 2001 —
Supplement 16 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 15 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 14 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 13 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 12 Labeling Approved July 30, 2001 —
Supplement 11 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 10 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 9 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 7 Labeling Approved July 30, 2001 —
Supplement 6 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 5 Manufacturing (CMC) Approved July 30, 2001 —
Supplement 4 Labeling Approved March 27, 2001 —
Supplement 2 Manufacturing (CMC) Approved January 28, 2000 —
Supplement 1 Labeling Approved April 26, 1999 —
Original application 1 Approved December 22, 1998 —

Review documents

  • 0 · Original application · December 22, 1998
  • 0 · Original application · December 22, 1998
  • 0 · Original application · December 22, 1998

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260724). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260724 HUMAN OTC DRUG · 20260413 HUMAN OTC DRUG · 20250901 HUMAN OTC DRUG · 20250512

Indications and Usage

openFDA Drug Labeling

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

Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

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. If possible, use weight to dose; otherwise use age. • use only enclosed dosing cup. Do not use any other dosing device. • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day • replace original bottle cap to maintain child resistance • wash dosage cup after each use Dosing Chart Weight (lb) Age (yr) Dose (mL)** under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL ** or as directed by a doctor

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 • give 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 )

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

openFDA Drug Labeling

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

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

Drug Facts Active ingredient (in each 5 mL).......................................................................Purpose Ibuprofen 100 mg (NSAID)*................................................................................Pain reliever/Fever reducer *nonsteroidal anti-inflammatory drug

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Children’s Ibuprofen Oral Suspension 100 mg per 5 mL NDC 72162-2286-2: 118 mL in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

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 III November 11, 2020 Aurobindo Pharma USA Inc. Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. 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
10202-150-24 10202-150 7-Eleven 1 BOTTLE in 1 CARTON (10202-150-24) / 120 mL in 1 BOTTLE March 28, 2022
10202-711-24 10202-711 7-Eleven 1 BOTTLE in 1 CARTON (10202-711-24) / 120 mL in 1 BOTTLE May 6, 2019
72888-479-01 72888-479 Advagen Pharma Ltd. 1 BOTTLE in 1 CARTON (72888-479-01) / 120 mL in 1 BOTTLE March 5, 2026
72288-392-34 72288-392 Amazon.com Services LLC 1 BOTTLE in 1 CARTON (72288-392-34) / 240 mL in 1 BOTTLE (72288-392-01) August 17, 2026
60687-743-17 60687-743 American Health Packaging 10 TRAY in 1 CASE (60687-743-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-743-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-743-40) December 1, 2023
58602-002-20 58602-002 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-002-20) / 240 mL in 1 BOTTLE June 16, 2021
58602-002-24 58602-002 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-002-24) / 120 mL in 1 BOTTLE June 16, 2021
58602-003-20 58602-003 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-003-20) / 240 mL in 1 BOTTLE June 16, 2021
58602-003-24 58602-003 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-003-24) / 120 mL in 1 BOTTLE June 16, 2021
58602-008-24 58602-008 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-008-24) / 120 mL in 1 BOTTLE August 13, 2020
21130-216-20 21130-216 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-216-20) / 240 mL in 1 BOTTLE March 21, 2025
68001-521-92 68001-521 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-521-92) / 120 mL in 1 BOTTLE September 12, 2022
68001-521-94 68001-521 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-521-94) / 240 mL in 1 BOTTLE May 31, 2023
72162-2285-2 72162-2285 Bryant Ranch Prepack 1 BOTTLE in 1 CARTON (72162-2285-2) / 118 mL in 1 BOTTLE April 30, 2024
72162-2286-2 72162-2286 Bryant Ranch Prepack 1 BOTTLE in 1 CARTON (72162-2286-2) / 118 mL in 1 BOTTLE April 30, 2024
59779-971-26 59779-971 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-971-26) / 120 mL in 1 BOTTLE January 29, 2014
55154-1577-5 55154-1577 Cardinal Health 107, LLC 5 CUP, UNIT-DOSE in 1 BAG (55154-1577-5) / 5 mL in 1 CUP, UNIT-DOSE April 13, 2004
79395-003-92 79395-003 Chalkboard Health 1 BOTTLE in 1 CARTON (79395-003-92) / 120 mL in 1 BOTTLE August 1, 2020
37808-200-26 37808-200 H E B 1 BOTTLE in 1 CARTON (37808-200-26) / 120 mL in 1 BOTTLE June 19, 2002
69256-634-03 69256-634 Harris Teeter, LLC 1 BOTTLE in 1 CARTON (69256-634-03) / 120 mL in 1 BOTTLE February 3, 2025
42507-685-26 42507-685 HyVee Inc 1 BOTTLE in 1 CARTON (42507-685-26) / 118 mL in 1 BOTTLE (42507-685-00) September 19, 2011
30142-281-08 30142-281 KROGER COMPANY 1 BOTTLE in 1 CARTON (30142-281-08) / 240 mL in 1 BOTTLE June 15, 2024
81033-019-01 81033-019 Kesin Pharma Corporation 100 CUP, UNIT-DOSE in 1 CASE (81033-019-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05) November 1, 2025
81033-019-02 81033-019 Kesin Pharma Corporation 100 CUP, UNIT-DOSE in 1 CASE (81033-019-02) / 10 mL in 1 CUP, UNIT-DOSE (81033-019-10) November 1, 2025
30142-965-08 30142-965 Kroger Company 1 BOTTLE in 1 CARTON (30142-965-08) / 120 mL in 1 BOTTLE May 14, 2021
41250-419-26 41250-419 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-419-26) / 120 mL in 1 BOTTLE April 23, 2014
41250-419-34 41250-419 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-419-34) / 240 mL in 1 BOTTLE April 23, 2014
41250-685-26 41250-685 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-685-26) / 120 mL in 1 BOTTLE September 3, 2008
41250-685-34 41250-685 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-685-34) / 240 mL in 1 BOTTLE September 3, 2008
68071-5290-4 68071-5290 NuCare Pharmaceuticals, Inc. 1 BOTTLE in 1 CARTON (68071-5290-4) / 118 mL in 1 BOTTLE May 27, 2026
45802-133-26 45802-133 Padagis Israel Pharmaceuticals Ltd 1 BOTTLE in 1 CARTON (45802-133-26) / 118 mL in 1 BOTTLE April 9, 2014
45802-140-26 45802-140 Padagis Israel Pharmaceuticals Ltd 1 BOTTLE in 1 CARTON (45802-140-26) / 118 mL in 1 BOTTLE April 9, 2014
68094-494-61 68094-494 Precision Dose Inc. 10 TRAY in 1 CASE (68094-494-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-494-59) April 13, 2004
68094-494-62 68094-494 Precision Dose Inc. 3 TRAY in 1 CASE (68094-494-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-494-59) April 13, 2004
68094-503-61 68094-503 Precision Dose Inc. 10 TRAY in 1 CASE (68094-503-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59) September 14, 2006
68094-503-62 68094-503 Precision Dose Inc. 3 TRAY in 1 CASE (68094-503-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59) September 14, 2006
68788-4031-1 68788-4031 Preferred Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (68788-4031-1) / 118 mL in 1 BOTTLE September 29, 2025
52412-911-04 52412-911 Randob Labs., Ltd. 1 BOTTLE in 1 CARTON (52412-911-04) / 120 mL in 1 BOTTLE July 15, 2023
11822-0166-3 11822-0166 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-0166-3) / 240 mL in 1 BOTTLE May 8, 2008
11822-0166-4 11822-0166 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-0166-4) / 120 mL in 1 BOTTLE May 10, 2002
11822-1685-0 11822-1685 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-1685-0) / 120 mL in 1 BOTTLE April 7, 2023
11822-9998-8 11822-9998 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-9998-8) / 240 mL in 1 BOTTLE June 15, 2022
21130-506-26 21130-506 Safeway 1 BOTTLE in 1 CARTON (21130-506-26) / 120 mL in 1 BOTTLE July 3, 2025
21130-510-26 21130-510 Safeway 1 BOTTLE in 1 CARTON (21130-510-26) / 120 mL in 1 BOTTLE June 11, 2025
0363-8901-24 0363-8901 WALGREEN CO. 1 BOTTLE in 1 CARTON (0363-8901-24) / 120 mL in 1 BOTTLE January 11, 2024
0363-8901-37 0363-8901 WALGREEN CO. 2 BOTTLE in 1 CARTON (0363-8901-37) / 120 mL in 1 BOTTLE January 11, 2024
10202-150 10202-150 7-Eleven — March 28, 2022
10202-711 10202-711 7-Eleven — May 6, 2019
72888-479 72888-479 Advagen Pharma Ltd. — March 5, 2026
72288-392 72288-392 Amazon.com Services LLC — August 17, 2026
60687-743 60687-743 American Health Packaging — December 1, 2023
58602-002 58602-002 Aurohealth LLC — June 16, 2021
58602-003 58602-003 Aurohealth LLC — June 16, 2021
58602-008 58602-008 Aurohealth LLC — August 13, 2020
21130-216 21130-216 Better Living Brands, LLC — March 21, 2025
68001-521 68001-521 BluePoint Laboratories — September 12, 2022
72162-2285 72162-2285 Bryant Ranch Prepack — April 9, 2014
72162-2286 72162-2286 Bryant Ranch Prepack — April 9, 2014
59779-971 59779-971 CVS Pharmacy — January 29, 2014
55154-1577 55154-1577 Cardinal Health 107, LLC — April 13, 2004
79395-003 79395-003 Chalkboard Health — August 1, 2020
37808-200 37808-200 H E B — June 19, 2002
69256-634 69256-634 Harris Teeter, LLC — February 3, 2025
42507-685 42507-685 HyVee Inc — September 30, 1997
30142-281 30142-281 KROGER COMPANY — June 15, 2024
81033-019 81033-019 Kesin Pharma Corporation — April 28, 2011
30142-965 30142-965 Kroger Company — June 27, 2017
41250-419 41250-419 Meijer Distribution Inc — April 23, 2014
41250-685 41250-685 Meijer Distribution Inc — September 3, 2008
68071-5290 68071-5290 NuCare Pharmaceuticals, Inc. — April 9, 2014
45802-133 45802-133 Padagis Israel Pharmaceuticals Ltd — April 9, 2014
45802-140 45802-140 Padagis Israel Pharmaceuticals Ltd — April 9, 2014
68094-494 68094-494 Precision Dose Inc. — April 13, 2004
68094-503 68094-503 Precision Dose Inc. — September 14, 2006
68788-4031 68788-4031 Preferred Pharmaceuticals Inc. — September 29, 2025
52412-911 52412-911 Randob Labs., Ltd. — July 15, 2023
11822-0166 11822-0166 Rite Aid Corporation — May 10, 2002
11822-1685 11822-1685 Rite Aid Corporation — April 7, 2023
11822-9998 11822-9998 Rite Aid Corporation — June 27, 2017
21130-506 21130-506 Safeway — July 3, 2025
21130-510 21130-510 Safeway — June 11, 2025
0363-8901 0363-8901 WALGREEN CO. — January 11, 2024

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 · 12 sections on this page.