{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "spl_product_data_elements": [ "Curist Acid Relief Famotidine 20 mg HYPROMELLOSE 2910 (6 MPA.S) TALC TITANIUM DIOXIDE SODIUM STARCH GLYCOLATE TYPE A MAGNESIUM STEARATE TRIACETIN POLYETHYLENE GLYCOL 4000 FAMOTIDINE FAMOTIDINE MICROCRYSTALLINE CELLULOSE HYDROXYPROPYL CELLULOSE (110000 WAMW) STARCH, CORN V;15 white to off-white" ], "spl_unclassified_section": [ "curistrelief.com Important: Read all directions and warnings before use. Tamper Evident: do not use if imprinted inner safety seal is torn or missing", "Drug Facts", "(CONTINUED ON BACK OF LABEL) REV: 032-23-02 NDC 72559-032-23 Distributed by: Little Pharma, Inc. New York, NY 10023 | Made in India *Maximum strength famotidine tablet available over-the-counter (OTC) without a prescription PEEL HERE", "REV: 032-23-02 STOP PEELING" ], "active_ingredient": [ "Active ingredient (in each tablet) Famotidine USP, 20 mg" ], "purpose": [ "Purpose Acid reducer" ], "indications_and_usage": [ "Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages" ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lighheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days 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. (1-800-222-1222)" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lighheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "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. (1-800-222-1222)" ], "dosage_and_administration": [ "adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor" ], "storage_and_handling": [ "Other information read the directions and warning before use store at 20°-25°C (68°-77°F) protect from moisture" ], "inactive_ingredient": [ "hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin" ], "questions": [ "Questions or comments? Call 1-844-243-1241 or email hi@curistrelief.com" ], "package_label_principal_display_panel": [ "curist Acid Relief Maximum Strength OTC* Famotidine Tablets USP, 20 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion Maximum Strength Without a Prescription* 300 Tablets famotidine 20mg 330ct" ], "set_id": "0fdfcc7c-aeed-6bd0-e063-6394a90ae52d", "id": "4c2614fe-f789-8512-e063-6394a90a22cf", "effective_time": "20260303", "version": "2", "openfda": { "application_number": [ "ANDA215822" ], "brand_name": [ "Curist Acid Relief" ], "generic_name": [ "FAMOTIDINE 20 MG" ], "manufacturer_name": [ "Little Pharma, Inc." ], "product_ndc": [ "72559-032" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FAMOTIDINE" ], "rxcui": [ "310273" ], "spl_id": [ "4c2614fe-f789-8512-e063-6394a90a22cf" ], "spl_set_id": [ "0fdfcc7c-aeed-6bd0-e063-6394a90ae52d" ], "package_ndc": [ "72559-032-23" ], "is_original_packager": [ true ], "upc": [ "0372559032239" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } } ] }