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Crcle Fexofenadine Hydrochloride

Fexofenadine Hydrochloride · Tablet

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

Crcle Fexofenadine Hydrochloride

Generic name

Fexofenadine Hydrochloride

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Innovus Pharmaceuticals, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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	180 mg/1	997501	View
Fexofenadine Hydrochloride	60 mg/1	997501	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

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

211075

Application type

ANDA · Abbreviated New Drug Application

Approval date

October 18, 2019

Sponsor

GRANULES

Products on application

Submissions recorded

Products approved under application 211075.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	TABLET		FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—
211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	TABLET		FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 211075.
Type	No.	Action	Status	Date	Review
Supplement	8	Labeling	Approved	January 4, 2024	Standard
Original application	1		Approved	October 18, 2019	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230408). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20230408

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 adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg) take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) children under 12 years of age do not use 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 Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 180 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
57483-230-01	57483-230	Innovus Pharmaceuticals, Inc.	100 TABLET in 1 CONTAINER (57483-230-01)	April 28, 2023
57483-240-02	57483-240	Innovus Pharmaceuticals, Inc.	150 TABLET in 1 CONTAINER (57483-240-02)	April 10, 2023
57483-230	57483-230	Innovus Pharmaceuticals, Inc.	—	December 18, 2020
57483-240	57483-240	Innovus Pharmaceuticals, Inc.	—	December 18, 2020

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.