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Childrens Allergy

Fexofenadine HCL · 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 Allergy
Generic name
Fexofenadine HCL
Dosage form
Suspension
Route
Oral
Marketing category
ANDA · ANDA
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
6
Packages
6
Data completeness
82% 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
12

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@FDANDC Directory
Application number
203330
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 18, 2014
Sponsor
P AND L
Products on application
2
Submissions recorded
2
Products approved under application 203330.
Product Trade name Form Strength Ingredient Status TE Flags
203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY SUSPENSION FEXOFENADINE HYDROCHLORIDE Over-the-counter —
203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES SUSPENSION FEXOFENADINE HYDROCHLORIDE Over-the-counter — RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
No
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 203330.
Type No. Action Status Date Review
Supplement 5 Labeling Approved March 3, 2020 Standard
Original application 1 Approved November 18, 2014 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260812). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260812 HUMAN OTC DRUG · 20260625 HUMAN OTC DRUG · 20260506

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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 (1-800-222-1222) 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, USP 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
51316-260-04 51316-260 CVS PHARMACY, INC 1 BOTTLE, PLASTIC in 1 BOX (51316-260-04) / 118 mL in 1 BOTTLE, PLASTIC October 15, 2023
49035-208-04 49035-208 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 BOTTLE, PLASTIC in 1 CARTON (49035-208-04) / 118 mL in 1 BOTTLE, PLASTIC July 1, 2020
55319-923-04 55319-923 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-923-04) / 118 mL in 1 BOTTLE, PLASTIC July 1, 2023
37808-623-04 37808-623 H E B 1 BOTTLE, PLASTIC in 1 CARTON (37808-623-04) / 118 mL in 1 BOTTLE, PLASTIC April 30, 2021
61269-527-94 61269-527 H2-Pharma, LLC 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE July 18, 2022
79903-249-04 79903-249 WALMART INC. (see also Equate) 1 BOTTLE, PLASTIC in 1 BOX (79903-249-04) / 118 mL in 1 BOTTLE, PLASTIC March 1, 2024
51316-260 51316-260 CVS PHARMACY, INC — October 15, 2023
49035-208 49035-208 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — July 1, 2020
55319-923 55319-923 Family Dollar (FAMILY WELLNESS) — July 1, 2023
37808-623 37808-623 H E B — April 30, 2021
61269-527 61269-527 H2-Pharma, LLC — July 18, 2022
79903-249 79903-249 WALMART INC. (see also Equate) — March 1, 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 · 11 sections on this page.