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Dye Free 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
Dye Free Childrens Ibuprofen
Generic name
Ibuprofen
Dosage form
Suspension
Route
Oral
Marketing category
ANDA · ANDA
Labeler
PAI Holdings, LLC dba PAI Pharma
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
4
Packages
7
Data completeness
76% 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
Ibuprofen 200 mg/10mL 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension
Route of administration
Oral
Presentations
11

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
210602
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 23, 2018
Sponsor
ANNORA PHARMA
Products on application
1
Submissions recorded
1
Products approved under application 210602.
Product Trade name Form Strength Ingredient Status TE Flags
210602-001 IBUPROFEN SUSPENSION IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 210602.
Type No. Action Status Date Review
Original application 1 Approved November 23, 2018 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250501). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250501 HUMAN OTC DRUG · 20250212 HUMAN OTC DRUG · 20250131

Indications and Usage

openFDA Drug Labeling

USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Purposes Pain reliever/fever reducer

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 Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 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 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)

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 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 the 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, USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

How Supplied / Storage and Handling

openFDA Drug Labeling

How Supplied NDC 68094-600-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-600-62 5 mL per unit dose cup Thirty (30) cups per shipper

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.

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
51316-914-03 51316-914 CVS 1 BOTTLE in 1 CARTON (51316-914-03) / 120 mL in 1 BOTTLE May 1, 2025
0121-1022-00 0121-1022 PAI Holdings, LLC dba PAI Pharma 10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE November 3, 2023
0121-1022-05 0121-1022 PAI Holdings, LLC dba PAI Pharma 10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE November 3, 2023
0121-2044-00 0121-2044 PAI Holdings, LLC dba PAI Pharma 10 CUP, UNIT-DOSE in 1 CASE (0121-2044-00) / 10 mL in 1 CUP, UNIT-DOSE November 3, 2023
0121-2044-10 0121-2044 PAI Holdings, LLC dba PAI Pharma 10 CUP, UNIT-DOSE in 1 TRAY (0121-2044-10) / 10 mL in 1 CUP, UNIT-DOSE November 3, 2023
68094-600-61 68094-600 Precision Dose Inc. 10 TRAY in 1 CASE (68094-600-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59) August 26, 2015
68094-600-62 68094-600 Precision Dose Inc. 3 TRAY in 1 CASE (68094-600-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59) August 26, 2015
51316-914 51316-914 CVS — May 1, 2025
0121-1022 0121-1022 PAI Holdings, LLC dba PAI Pharma — November 3, 2023
0121-2044 0121-2044 PAI Holdings, LLC dba PAI Pharma — November 3, 2023
68094-600 68094-600 Precision Dose Inc. — August 26, 2015

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

Generated September 25, 2026 · 10 sections on this page.