{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Curist Hives Relief Fexofenadine Hydrochloride 180 mg FERRIC OXIDE RED LACTOSE MONOHYDRATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE ANHYDROUS LACTOSE STEARIC ACID FERRIC OXIDE YELLOW CROSCARMELLOSE SODIUM TITANIUM DIOXIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED SG;202" ], "spl_unclassified_section": [ "Drug Facts", "(CONTINUED ON BACK OF LABEL) Rev: 028-40-02 Distributed by: Little Pharma, Inc. | New York, NY 10023 PEEL HERE" ], "active_ingredient": [ "Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 180 mg" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring." ], "warnings": [ "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 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 professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitue 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 occuring. 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": [ "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 occuring. 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_doctor": [ "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": [ "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": [ "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 180 mg 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" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
" ], "storage_and_handling": [ "Other information each tablet contains: sodium 8.2 mg store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture this product meets the requirements of USP Dissolution Test 2" ], "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, opadry pink 03B84893 containing hypromellose, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide." ], "questions": [ "Questions or comments? Call 1-844-243-1241 or email hi@curistrelief.com" ], "recent_major_changes": [ "" ], "package_label_principal_display_panel": [ "curist Hives Relief Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24 Hour Relief of Itching due to Hives Non-Drowsy 60 Tablets curistrelief.com Tamper Evident: Do not use if imprinted inner safety seal is torn or missing. Fexofenadine 180mg 60ct" ], "set_id": "04c75e93-b1f4-2546-e063-6394a90af0e1", "id": "4c259f31-d98c-4491-e063-6294a90a68cd", "effective_time": "20260303", "version": "3", "openfda": { "application_number": [ "ANDA204507" ], "brand_name": [ "Curist Hives Relief" ], "generic_name": [ "FEXOFENADINE HYDROCHLORIDE 180 MG" ], "manufacturer_name": [ "Little Pharma, Inc." ], "product_ndc": [ "72559-028" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE" ], "rxcui": [ "997420" ], "spl_id": [ "4c259f31-d98c-4491-e063-6294a90a68cd" ], "spl_set_id": [ "04c75e93-b1f4-2546-e063-6394a90af0e1" ], "package_ndc": [ "72559-028-40" ], "is_original_packager": [ true ], "unii": [ "2S068B75ZU" ] } } ] }