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fexofenadine hcl
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 |
|---|---|---|---|---|---|---|---|
| 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| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | September 16, 2015 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251022). 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.
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 LabelingPurpose Antihistamine
Purpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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
Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet 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
Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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
Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet 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 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 swelling in or around mouth trouble speaking 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 profession 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 Ask a doctor before use if you have 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 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. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks 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.
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 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
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have 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 before use if you have kidney disease. Your doctor should determine if you need a different dose.
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
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingHIVES Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Fexofenadine Hydrochloride 60mg Tablets NDC 71335-2165-1: 30 Tablets in a BOTTLE NDC 71335-2165-2: 10 Tablets in a BOTTLE NDC 71335-2165-3: 60 Tablets in a BOTTLE NDC 71335-2165-4: 90 Tablets in a BOTTLE NDC 71335-2165-5: 14 Tablets in a BOTTLE NDC 71335-2165-6: 20 Tablets in a BOTTLE NDC 71335-2165-7: 12 Tablets in a BOTTLE store between 20° and 25°C (68° and 77°F). protect from excessive moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERSAttributed 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 71399-8659-1 | 71399-8659 | AKRON PHARMA INC | 100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1) | November 1, 2021 |
| 71399-8659-5 | 71399-8659 | AKRON PHARMA INC | 500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5) | February 2, 2024 |
| 80513-506-01 | 80513-506 | Advanced Rx LLC | 100 TABLET, FILM COATED in 1 BOTTLE (80513-506-01) | September 10, 2024 |
| 71610-893-53 | 71610-893 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-893-53) | April 2, 2025 |
| 71610-893-60 | 71610-893 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-893-60) | April 2, 2025 |
| 71610-893-70 | 71610-893 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70) | April 2, 2025 |
| 71610-905-30 | 71610-905 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30) | May 7, 2025 |
| 71610-905-53 | 71610-905 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53) | May 7, 2025 |
| 71610-905-60 | 71610-905 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60) | May 7, 2025 |
| 71610-905-80 | 71610-905 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80) | May 7, 2025 |
| 71335-2165-1 | 71335-2165 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1) | September 6, 2024 |
| 71335-2165-2 | 71335-2165 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2) | August 25, 2022 |
| 71335-2165-3 | 71335-2165 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3) | September 6, 2024 |
| 71335-2165-4 | 71335-2165 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4) | September 6, 2024 |
| 71335-2165-5 | 71335-2165 | Bryant Ranch Prepack | 14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5) | September 6, 2024 |
| 71335-2165-6 | 71335-2165 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6) | September 6, 2024 |
| 71335-2165-7 | 71335-2165 | Bryant Ranch Prepack | 12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7) | November 8, 2022 |
| 69230-201-01 | 69230-201 | Camber Consumer Care | 100 TABLET, FILM COATED in 1 BOTTLE (69230-201-01) | December 8, 2021 |
| 69230-201-05 | 69230-201 | Camber Consumer Care | 500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05) | December 8, 2021 |
| 69230-202-01 | 69230-202 | Camber Consumer Care | 1 BOTTLE in 1 CARTON (69230-202-01) / 100 TABLET, FILM COATED in 1 BOTTLE | September 16, 2015 |
| 69230-202-05 | 69230-202 | Camber Consumer Care | 500 TABLET, FILM COATED in 1 BOTTLE (69230-202-05) | September 16, 2015 |
| 69230-202-11 | 69230-202 | Camber Consumer Care | 1000 TABLET, FILM COATED in 1 BOTTLE (69230-202-11) | September 16, 2015 |
| 69230-202-30 | 69230-202 | Camber Consumer Care | 1 BOTTLE in 1 CARTON (69230-202-30) / 30 TABLET, FILM COATED in 1 BOTTLE | September 16, 2015 |
| 69230-202-45 | 69230-202 | Camber Consumer Care | 1 BOTTLE in 1 CARTON (69230-202-45) / 45 TABLET, FILM COATED in 1 BOTTLE | September 16, 2015 |
| 69230-202-60 | 69230-202 | Camber Consumer Care | 1 BOTTLE in 1 CARTON (69230-202-60) / 60 TABLET, FILM COATED in 1 BOTTLE | September 16, 2015 |
| 69230-202-90 | 69230-202 | Camber Consumer Care | 1 BOTTLE in 1 CARTON (69230-202-90) / 90 TABLET, FILM COATED in 1 BOTTLE | September 16, 2015 |
| 0904-7192-04 | 0904-7192 | Major Pharmaceuticals | 100 TABLET, FILM COATED in 1 BOTTLE (0904-7192-04) | August 20, 2024 |
| 0904-7192-40 | 0904-7192 | Major Pharmaceuticals | 500 TABLET, FILM COATED in 1 BOTTLE (0904-7192-40) | August 26, 2021 |
| 0904-7192-60 | 0904-7192 | Major Pharmaceuticals | 100 TABLET, FILM COATED in 1 BOTTLE (0904-7192-60) | August 26, 2021 |
| 0904-7486-02 | 0904-7486 | Major Pharmaceuticals | 30 TABLET, FILM COATED in 1 BOTTLE (0904-7486-02) | August 20, 2024 |
| 0904-7486-40 | 0904-7486 | Major Pharmaceuticals | 500 TABLET, FILM COATED in 1 BOTTLE (0904-7486-40) | August 20, 2024 |
| 0904-7486-60 | 0904-7486 | Major Pharmaceuticals | 100 TABLET, FILM COATED in 1 BOTTLE (0904-7486-60) | August 20, 2024 |
| 63187-921-20 | 63187-921 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-921-20) | October 2, 2017 |
| 63187-921-30 | 63187-921 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30) | October 2, 2017 |
| 63187-921-60 | 63187-921 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (63187-921-60) | October 2, 2017 |
| 63187-921-90 | 63187-921 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (63187-921-90) | October 2, 2017 |
| 77771-201-01 | 77771-201 | Radha Pharmaceuticals | 100 TABLET, FILM COATED in 1 BOTTLE (77771-201-01) | March 10, 2025 |
| 77771-201-05 | 77771-201 | Radha Pharmaceuticals | 500 TABLET, FILM COATED in 1 BOTTLE (77771-201-05) | March 10, 2025 |
| 77771-202-01 | 77771-202 | Radha Pharmaceuticals | 100 TABLET, FILM COATED in 1 BOTTLE (77771-202-01) | March 10, 2025 |
| 77771-202-05 | 77771-202 | Radha Pharmaceuticals | 500 TABLET, FILM COATED in 1 BOTTLE (77771-202-05) | March 10, 2025 |
| 77771-202-30 | 77771-202 | Radha Pharmaceuticals | 30 TABLET, FILM COATED in 1 BOTTLE (77771-202-30) | March 10, 2025 |
| 50228-201-01 | 50228-201 | ScieGen Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01) | December 26, 2014 |
| 50228-201-02 | 50228-201 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02) | December 26, 2014 |
| 50228-201-03 | 50228-201 | ScieGen Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03) | December 26, 2014 |
| 50228-201-04 | 50228-201 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04) | December 26, 2014 |
| 50228-202-01 | 50228-202 | ScieGen Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (50228-202-01) | December 26, 2014 |
| 50228-202-02 | 50228-202 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-202-02) | December 26, 2014 |
| 50228-202-03 | 50228-202 | ScieGen Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (50228-202-03) | December 26, 2014 |
| 50228-202-04 | 50228-202 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-202-04) | December 26, 2014 |
| 70677-1239-1 | 70677-1239 | Strategic Sourcing Services, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70677-1239-1) | February 22, 2024 |
| 71399-8659 | 71399-8659 | AKRON PHARMA INC | — | December 26, 2014 |
| 80513-506 | 80513-506 | Advanced Rx LLC | — | September 16, 2015 |
| 71610-893 | 71610-893 | Aphena Pharma Solutions - Tennessee, LLC | — | August 20, 2024 |
| 71610-905 | 71610-905 | Aphena Pharma Solutions - Tennessee, LLC | — | March 10, 2025 |
| 71335-2165 | 71335-2165 | Bryant Ranch Prepack | — | August 26, 2021 |
| 69230-201 | 69230-201 | Camber Consumer Care | — | December 8, 2021 |
| 69230-202 | 69230-202 | Camber Consumer Care | — | September 16, 2015 |
| 0904-7192 | 0904-7192 | Major Pharmaceuticals | — | August 26, 2021 |
| 0904-7486 | 0904-7486 | Major Pharmaceuticals | — | August 20, 2024 |
| 63187-921 | 63187-921 | Proficient Rx LP | — | September 16, 2015 |
| 77771-201 | 77771-201 | Radha Pharmaceuticals | — | March 10, 2025 |
| 77771-202 | 77771-202 | Radha Pharmaceuticals | — | March 10, 2025 |
| 50228-201 | 50228-201 | ScieGen Pharmaceuticals, Inc. | — | December 26, 2014 |
| 50228-202 | 50228-202 | ScieGen Pharmaceuticals, Inc. | — | December 26, 2014 |
| 70677-1239 | 70677-1239 | Strategic Sourcing Services, LLC | — | February 22, 2024 |
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 · 11 sections on this page.