Concentrated ibuprofen infants — Suspension/ Drops

Overview

Brand name

Concentrated ibuprofen infants

Generic name

Ibuprofen

Dosage form

Suspension/ Drops

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Chain Drug Marketing Association Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

3

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	50 mg/1.25mL	310965	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Suspension/ Drops

Route of administration

Oral

Presentations

6

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@FDA NDC Directory

Application number

210755

Application type

ANDA · Abbreviated New Drug Application

Approval date

September 26, 2018

Sponsor

GUARDIAN DRUG

Products on application

1

Submissions recorded

1

Products approved under application 210755.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
210755-001	IBUPROFEN	SUSPENSION/DROPS		IBUPROFEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 210755.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	September 26, 2018	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20231103). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20231103 HUMAN OTC DRUG · 20221128

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

PURPOSE 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 find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 years 1.875 mL

Warnings

openFDA Drug Labeling

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 you 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

openFDA Drug Labeling

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

openFDA Drug Labeling

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 1.25 mL) Ibuprofen, USP 50 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.

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
83324-005-30	83324-005	Chain Drug Marketing Association Inc.	1 BOTTLE in 1 CARTON (83324-005-30) / 30 mL in 1 BOTTLE	November 3, 2023
53041-637-09	53041-637	Guardian Drug Company	1 BOTTLE in 1 CARTON (53041-637-09) / 30 mL in 1 BOTTLE	October 3, 2018
49035-635-09	49035-635	Wal-Mart Stores, Inc.	1 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLE	June 20, 2019
83324-005	83324-005	Chain Drug Marketing Association Inc.	—	November 3, 2023
53041-637	53041-637	Guardian Drug Company	—	October 3, 2018
49035-635	49035-635	Wal-Mart Stores, Inc.	—	June 20, 2019

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.