{ "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": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Zantac 360 Famotidine tablet, film-coated MAGNESIUM STEARATE TALC FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A CORN CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) STARCH, CORN TITANIUM DIOXIDE FAMOTIDINE FAMOTIDINE FERRIC OXIDE RED CC;59 Rounded edges; biconvex Zantac 360, Travel BASIX Famotidine tablet, film-coated MAGNESIUM STEARATE TALC FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A CORN CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) STARCH, CORN TITANIUM DIOXIDE FAMOTIDINE FAMOTIDINE FERRIC OXIDE RED CC;59 Rounded edges; biconvex" ], "spl_unclassified_section": [ "Drug Facts", "Other information Other information read the directions and warnings before use keep the carton. It contains important information. store at 20º-25ºC (68º-77ºF) protect from moisture", "Product manufactured for: Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 ©2021 Made in India Product repackaged and distributed by: Lil' Drug Store Products, Inc. 9300 Earhart Lane SW, Cedar Rapids, IA 52404 1-877-507-6516 (M-F 8AM-4:30PM CST) www.lildrugstore.com 97585C-US-04-21" ], "active_ingredient": [ "Active Ingredient Active ingredient (in each tablet) Famotidine USP 20 mg" ], "purpose": [ "Purpose Purpose Acid reducer" ], "indications_and_usage": [ "Uses 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 foods and beverages" ], "warnings": [ "Warnings Alergy alert Allergy alert: Do not use if you are allergic to famotidine or other acid reducers 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 a doctor before use 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 lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease Ask a 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 and ask a doctor 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 healthcare 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 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 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 lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness 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 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 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 healthcare 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": [ "Directions Directions 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" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide" ], "questions": [ "Questions or comments? Questions or comments? call 1-800-633-1610 or visit www.zantacotc.com" ], "package_label_principal_display_panel": [ "PDP/Package NEW FORMULA MAXIMUM STRENGTH See New Warnings Zantac 360°™ Famotidine Tablets USP 20 mg / Acid Reducer JUST ONE TABLET PREVENTS & RELIEVES HEARTBURN DUE TO ACID INDIGESTION [tablet image] Actual Size 5 Tablets (5 Doses) [Lil' Drug Store logo] PDP", "Zantac 360°™, Lil' Drug Store ® - PDP/Package NEW FORMULA MAXIMUM STRENGTH See New Warnings Zantac 360°™ Famotidine Tablets USP 20 mg / Acid Reducer JUST ONE TABLET PREVENTS & RELIEVES HEARTBURN DUE TO ACID INDIGESTION [tablet image] Actual Size 2 Tablets (2 Doses) [Lil' Drug Store logo] PDP/Package", "Zantac 360°™, Travel BASIX NEW FORMULA See New Warnings MAXIMUM STRENGTH Zantac 360°™ Famotidine Tablets USP 20 mg / Acid Reducer JUST ONE TABLET PREVENTS & RELIEVES HEARTBURN DUE TO ACID INDIGESTION [tablet image] Actual Size 2 Tablets [Travel BASIX logo] PDP/Package" ], "set_id": "ea38535a-c9db-d03f-e053-2a95a90adf2d", "id": "274bc24b-823e-516d-e063-6394a90a2680", "effective_time": "20241119", "version": "3", "openfda": { "application_number": [ "ANDA206531" ], "brand_name": [ "Zantac 360, Travel BASIX", "Zantac 360" ], "generic_name": [ "FAMOTIDINE TABLET, FILM-COATED" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc" ], "product_ndc": [ "66715-6458", "66715-9758" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FAMOTIDINE" ], "rxcui": [ "310273", "2609246" ], "spl_id": [ "274bc24b-823e-516d-e063-6394a90a2680" ], "spl_set_id": [ "ea38535a-c9db-d03f-e053-2a95a90adf2d" ], "package_ndc": [ "66715-9758-5", "66715-9758-2", "66715-6458-2" ], "is_original_packager": [ true ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } } ] }