Childrens Fexofenadine Hydrochloride — Suspension

Overview

Brand name

Childrens Fexofenadine Hydrochloride Allergy

Generic name

Fexofenadine Hydrochloride

Dosage form

Suspension

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Wal-Mart Stores Inc

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

5

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
Fexofenadine Hydrochloride	30 mg/5mL	997501	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Suspension

Route of administration

Oral

Presentations

8

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
Histamine H1 Receptor Antagonists [MoA]	MoA	All 136 members
Histamine-1 Receptor Antagonist [EPC]	EPC	All 134 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

208123

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 9, 2017

Sponsor

TARO

Products on application

2

Submissions recorded

1

Products approved under application 208123.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
208123-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	SUSPENSION		FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—
208123-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	SUSPENSION		FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 208123.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	November 9, 2017	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260811). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260811 HUMAN OTC DRUG · 20250611

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions shake well before using use only with enclosed dosing cup Note: mL = milliliters adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions ) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. 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 Labeling

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient ( in each 5 mL ) Fexofenadine HCl 30 mg

Adverse event reports

Source: openFDA FAERS

21,660

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: FEXOFENADINE HYDROCHLORIDE. 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
51672-2141-1	51672-2141	Sun Pharmaceutical Industries, Inc.	1 BOTTLE in 1 CARTON (51672-2141-1) / 240 mL in 1 BOTTLE	January 24, 2024
51672-2141-8	51672-2141	Sun Pharmaceutical Industries, Inc.	1 BOTTLE in 1 CARTON (51672-2141-8) / 120 mL in 1 BOTTLE	January 24, 2024
79903-306-04	79903-306	Wal-Mart Stores Inc	1 BOTTLE in 1 CARTON (79903-306-04) / 120 mL in 1 BOTTLE	December 6, 2024
0363-2141-01	0363-2141	Walgreens Company	1 BOTTLE in 1 CARTON (0363-2141-01) / 240 mL in 1 BOTTLE	December 6, 2024
0363-2141-08	0363-2141	Walgreens Company	1 BOTTLE in 1 CARTON (0363-2141-08) / 120 mL in 1 BOTTLE	December 6, 2024
51672-2141	51672-2141	Sun Pharmaceutical Industries, Inc.	—	January 24, 2024
79903-306	79903-306	Wal-Mart Stores Inc	—	December 6, 2024
0363-2141	0363-2141	Walgreens Company	—	December 6, 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

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