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Allergy Relief

Fexofenadine HCl · Capsule, Coated

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
Allergy Relief
Generic name
Fexofenadine HCl
Dosage form
Capsule, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Allegiant Health
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
9
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

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Coated
Route of administration
Oral
Presentations
11

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
204507
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 16, 2015
Sponsor
SCIEGEN PHARMS
Products on application
4
Submissions recorded
1
Products approved under application 204507.
Product Trade name Form Strength Ingredient Status TE Flags
204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204507-004 FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204507-005 FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 204507.
Type No. Action Status Date Review
Original application 1 Approved September 16, 2015 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20210323). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20210323 HUMAN OTC DRUG · 20200727

Indications and Usage

openFDA Drug Labeling

Use(s) 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 Adults and children 12 years of age and over take one 180 mg caplet with water, once a day; do not take more than 1 caplet in 24 hours 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 if an allergic reaction to this product occurs. Seek medical help right away. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or 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 if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Fexofenadine HCl 180mg

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
69168-413-03 69168-413 Allegiant Health 3 CAPSULE, COATED in 1 CARTON (69168-413-03) March 22, 2021
69168-413-06 69168-413 Allegiant Health 120 CAPSULE, COATED in 1 BOTTLE (69168-413-06) March 22, 2021
69168-413-14 69168-413 Allegiant Health 250 CAPSULE, COATED in 1 BOTTLE (69168-413-14) March 9, 2026
69168-413-30 69168-413 Allegiant Health 30 CAPSULE, COATED in 1 BOTTLE (69168-413-30) March 22, 2021
69168-413-80 69168-413 Allegiant Health 180 CAPSULE, COATED in 1 BOTTLE (69168-413-80) September 19, 2025
69168-413-82 69168-413 Allegiant Health 90 CAPSULE, COATED in 1 BOTTLE (69168-413-82) September 19, 2025
69168-416-03 69168-416 Allegiant Health 3 CAPSULE, COATED in 1 CARTON (69168-416-03) August 14, 2020
69168-416-06 69168-416 Allegiant Health 120 CAPSULE, COATED in 1 BOTTLE, PLASTIC (69168-416-06) August 14, 2020
69168-416-30 69168-416 Allegiant Health 30 CAPSULE, COATED in 1 BOTTLE (69168-416-30) August 14, 2020
69168-413 69168-413 Allegiant Health — March 22, 2021
69168-416 69168-416 Allegiant Health — December 26, 2014

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.