Childrens Allegra Allergy — Suspension

Overview

Brand name

Childrens Allegra Allergy

Generic name

Fexofenadine Hydrochloride

Dosage form

Suspension

Route

Oral

Marketing category

NDA · NDA

Labeler

Chattem, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

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

7

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

201373

Application type

NDA · New Drug Application

Approval date

January 24, 2011

Sponsor

CHATTEM SANOFI

Products on application

2

Submissions recorded

9

Products approved under application 201373.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
201373-001	CHILDREN'S ALLEGRA ALLERGY	SUSPENSION		FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—	RLD RS
201373-002	CHILDREN'S ALLEGRA HIVES	SUSPENSION		FEXOFENADINE HYDROCHLORIDE	Discontinued	—	RLD

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

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.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Use code	Submitted
8933097	August 2, 2030	001	No		February 19, 2015
8933097	August 2, 2030	002	No		February 19, 2015

Approval history

Source: Drugs@FDA

Most recent submissions on application 201373.
Type	No.	Action	Status	Date	Review
Supplement	13	Manufacturing (CMC)	Approved	December 27, 2022	N/A
Supplement	12	Manufacturing (CMC)	Approved	December 20, 2022	N/A
Supplement	11	Manufacturing (CMC)	Approved	March 17, 2021	N/A
Supplement	10	Labeling	Approved	November 2, 2020	Standard
Supplement	6	Labeling	Approved	June 15, 2016	Standard
Supplement	5	Labeling	Approved	April 28, 2013	Standard
Supplement	4	Labeling	Approved	August 23, 2012	Standard
Supplement	2	Labeling	Approved	February 23, 2012	Standard
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	January 24, 2011	Standard

Review documents

0 · Supplement · January 3, 2023
0 · Supplement · December 28, 2022
0 · Supplement · December 20, 2022
0 · Supplement · December 20, 2022
0 · Supplement · July 6, 2021
0 · Supplement · July 6, 2021
0 · Supplement · January 25, 2021
0 · Supplement · November 3, 2020
0 · Supplement · June 21, 2016
0 · Supplement · June 17, 2016
0 · Original application · November 26, 2013
0 · Supplement · October 2, 2013
0 · Supplement · April 30, 2013
0 · Supplement · August 27, 2012
0 · Supplement · February 27, 2012
0 · Original application · October 7, 2011
0 · Original application · October 7, 2011
0 · Original application · February 2, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260113). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260113

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water 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 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 Note: mL = milliliters

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 HCI 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
41167-4244-1	41167-4244	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4244-1) / 240 mL in 1 BOTTLE	March 3, 2011
41167-4244-4	41167-4244	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4244-4) / 120 mL in 1 BOTTLE	March 3, 2011
41167-4244-7	41167-4244	Chattem, Inc.	3 BOTTLE in 1 CELLO PACK (41167-4244-7) / 120 mL in 1 BOTTLE	March 3, 2011
41167-4246-2	41167-4246	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4246-2) / 240 mL in 1 BOTTLE	March 1, 2023
41167-4246-4	41167-4246	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4246-4) / 120 mL in 1 BOTTLE	March 1, 2023
41167-4244	41167-4244	Chattem, Inc.	—	March 3, 2011
41167-4246	41167-4246	Chattem, Inc.	—	March 3, 2011

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
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.