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HIVES RELIEF

Fexofenadine Hydrochloride · Tablet, Film 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
HIVES RELIEF
Generic name
Fexofenadine Hydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Walgreen Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
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
Cetirizine Hydrochloride 10 mg/1 1014678 View
Fexofenadine Hydrochloride 180 mg/1 997501 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
4

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
212971
Application type
ANDA · Abbreviated New Drug Application
Approval date
February 24, 2020
Sponsor
L PERRIGO CO
Products on application
2
Submissions recorded
3
Products approved under application 212971.
Product Trade name Form Strength Ingredient Status TE Flags
212971-001 FEXOFENADINE HYDROCHLORIDE TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
212971-002 FEXOFENADINE HYDROCHLORIDE TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 212971.
Type No. Action Status Date Review
Supplement 14 Manufacturing (CMC) Approved November 4, 2022 —
Supplement 9 Manufacturing (CMC) Approved July 8, 2022 Unknown
Original application 1 Approved February 24, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260722). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260722 HUMAN OTC DRUG · 20260316

Indications and Usage

openFDA Drug Labeling

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: ■ trouble swallowing ■ dizziness or loss of consciousness ■ swelling of tongue ■ trouble speaking ■ swelling in or around mouth ■ drooling ■ wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use ■ to prevent hives from any known cause such as: ■ foods ■ insect stings ■ medicines ■ latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have ■ liver or kidney disease. Your doctor should determine if you need a different dose. ■ hives that are an unusual color, look bruised or blistered ■ hives that do not itch Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product ■ drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ an allergic reaction to this product occurs. Seek medical help right away. ■ symptoms do not improve after 3 days of treatment ■ the hives have lasted more than 6 weeks If pregnant or breast-feeding: ■ If breast-feeding: not recommended ■ if pregnant: 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 ■ to prevent hives from any known cause such as: ■ foods ■ insect stings ■ medicines ■ latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have ■ liver or kidney disease. Your doctor should determine if you need a different dose. ■ hives that are an unusual color, look bruised or blistered ■ hives that do not itch

Stop use and ask a doctor if ■ an allergic reaction to this product occurs. Seek medical help right away. ■ symptoms do not improve after 3 days of treatment ■ the hives have lasted more than 6 weeks

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Cetirizine Hydrochloride USP, 10 mg

Adverse event reports

Source: openFDA FAERS
166,303
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: CETIRIZINE 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
0363-6340-13 0363-6340 WALGREEN COMPANY 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-6340-13) March 20, 2026
0363-4071-39 0363-4071 Walgreen Company 1 BOTTLE in 1 CARTON (0363-4071-39) / 30 TABLET, FILM COATED in 1 BOTTLE (0363-4071-30) July 10, 2026
0363-6340 0363-6340 WALGREEN COMPANY — March 20, 2026
0363-4071 0363-4071 Walgreen Company — July 10, 2026

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.