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HIVES RELIEF
Fexofenadine Hydrochloride · Tablet, Film Coated
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Purpose
openFDA Drug LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredient (in each tablet) Cetirizine Hydrochloride USP, 10 mg
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.