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Fexofenadine Hydrochloride
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 |
|---|---|---|---|---|---|---|---|
| 202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | TABLET | FEXOFENADINE HYDROCHLORIDE | Over-the-counter | — | ||
| 202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | TABLET | FEXOFENADINE HYDROCHLORIDE | Over-the-counter | — | ||
| 202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | TABLET | FEXOFENADINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 3 | Manufacturing (CMC) | Approved | September 15, 2017 | Unknown |
| Original application | 1 | Not Applicable | Approved | November 19, 2014 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260806). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses 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 LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 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 wheezing or problems breathing drooling 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 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.
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
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
Stop Use
openFDA Drug LabelingStop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) Fexofenadine HCl USP, 60 mg (for 60 mg) Fexofenadine HCl USP, 180 mg (for 180 mg)
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.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | January 31, 2024 | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | Completed |
| Class II | July 19, 2023 | L. Perrigo Company | Failed Impurities/Degradation Specifications | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 10202-229-66 | 10202-229 | 7-eleven | 1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK | January 15, 2015 |
| 46122-779-58 | 46122-779 | AMERISOURCE BERGEN | 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK | May 14, 2024 |
| 46122-779-61 | 46122-779 | AMERISOURCE BERGEN | 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE | May 14, 2024 |
| 46122-779-66 | 46122-779 | AMERISOURCE BERGEN | 1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE | May 14, 2024 |
| 73629-008-03 | 73629-008 | AMZ789 LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73629-008-03) | July 27, 2024 |
| 58602-876-09 | 58602-876 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-876-09) / 30 TABLET, FILM COATED in 1 BOTTLE | October 13, 2023 |
| 58602-876-40 | 58602-876 | Aurohealth LLC | 500 TABLET, FILM COATED in 1 BOTTLE (58602-876-40) | October 13, 2023 |
| 58602-876-60 | 58602-876 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-876-60) / 5 TABLET, FILM COATED in 1 BLISTER PACK | October 13, 2023 |
| 58602-877-09 | 58602-877 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-877-09) / 30 TABLET, FILM COATED in 1 BOTTLE | October 13, 2023 |
| 58602-877-40 | 58602-877 | Aurohealth LLC | 500 TABLET, FILM COATED in 1 BOTTLE (58602-877-40) | October 13, 2023 |
| 58602-877-74 | 58602-877 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-877-74) / 6 TABLET, FILM COATED in 1 BLISTER PACK | October 13, 2023 |
| 58602-878-09 | 58602-878 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-878-09) / 30 TABLET, FILM COATED in 1 BOTTLE | October 13, 2023 |
| 58602-878-40 | 58602-878 | Aurohealth LLC | 500 TABLET, FILM COATED in 1 BOTTLE (58602-878-40) | October 13, 2023 |
| 58602-878-60 | 58602-878 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-878-60) / 5 TABLET, FILM COATED in 1 BLISTER PACK | October 13, 2023 |
| 62207-889-49 | 62207-889 | Granules India Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (62207-889-49) | November 7, 2023 |
| 62207-889-51 | 62207-889 | Granules India Limited | 1 BOTTLE in 1 CARTON (62207-889-51) / 10 TABLET, FILM COATED in 1 BOTTLE | November 7, 2023 |
| 62207-889-60 | 62207-889 | Granules India Limited | 8 BLISTER PACK in 1 CARTON (62207-889-60) / 9 TABLET, FILM COATED in 1 BLISTER PACK | November 7, 2023 |
| 62207-891-49 | 62207-891 | Granules India Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (62207-891-49) | November 7, 2023 |
| 62207-891-51 | 62207-891 | Granules India Limited | 1 BOTTLE in 1 CARTON (62207-891-51) / 10 TABLET, FILM COATED in 1 BOTTLE | November 7, 2023 |
| 62207-891-58 | 62207-891 | Granules India Limited | 7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK | November 7, 2023 |
| 0615-8648-39 | 0615-8648 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8648-39) | June 23, 2026 |
| 51660-998-30 | 51660-998 | OHM LABORATORIES INC. | 1 BOTTLE in 1 CARTON (51660-998-30) / 30 TABLET, FILM COATED in 1 BOTTLE | April 29, 2022 |
| 51660-998-55 | 51660-998 | OHM LABORATORIES INC. | 1 BOTTLE in 1 CARTON (51660-998-55) / 150 TABLET, FILM COATED in 1 BOTTLE | April 29, 2022 |
| 45802-847-78 | 45802-847 | Padagis Israel Pharmaceuticals Ltd | 1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE | January 7, 2022 |
| 71205-739-30 | 71205-739 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (71205-739-30) | December 28, 2022 |
| 71205-739-60 | 71205-739 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (71205-739-60) | December 28, 2022 |
| 71205-739-90 | 71205-739 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (71205-739-90) | December 28, 2022 |
| 68210-2210-1 | 68210-2210 | SPIRIT PHARMACEUTICALS LLC | 100 TABLET, FILM COATED in 1 PACKAGE (68210-2210-1) | March 17, 2020 |
| 68210-4090-1 | 68210-4090 | SPIRIT PHARMACEUTICALS LLC | 100 TABLET, FILM COATED in 1 PACKAGE (68210-4090-1) | July 2, 2020 |
| 10202-229 | 10202-229 | 7-eleven | — | January 15, 2015 |
| 46122-779 | 46122-779 | AMERISOURCE BERGEN | — | May 14, 2024 |
| 73629-008 | 73629-008 | AMZ789 LLC | — | July 27, 2024 |
| 58602-876 | 58602-876 | Aurohealth LLC | — | October 13, 2023 |
| 58602-877 | 58602-877 | Aurohealth LLC | — | October 13, 2023 |
| 58602-878 | 58602-878 | Aurohealth LLC | — | October 13, 2023 |
| 62207-889 | 62207-889 | Granules India Limited | — | November 7, 2023 |
| 62207-891 | 62207-891 | Granules India Limited | — | November 7, 2023 |
| 0615-8648 | 0615-8648 | NCS HealthCare of KY, LLC dba Vangard Labs | — | April 29, 2022 |
| 51660-998 | 51660-998 | OHM LABORATORIES INC. | — | April 29, 2022 |
| 45802-847 | 45802-847 | Padagis Israel Pharmaceuticals Ltd | — | January 7, 2022 |
| 71205-739 | 71205-739 | Proficient Rx LP | — | January 7, 2022 |
| 68210-2210 | 68210-2210 | SPIRIT PHARMACEUTICALS LLC | — | March 17, 2020 |
| 68210-4090 | 68210-4090 | SPIRIT PHARMACEUTICALS LLC | — | July 2, 2020 |
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 |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 12 sections on this page.