{ "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": "2026-10-16", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Pepcid AC Famotidine CARNAUBA WAX HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN TALC TITANIUM DIOXIDE FAMOTIDINE FAMOTIDINE D-shaped PAC;20" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA Repackaged and distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW Cedar Rapids, IA 52404" ], "active_ingredient": [ "Active ingredient (in each tablet) Famotidine 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 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 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 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 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": [ "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" ], "storage_and_handling": [ "Other information read the directions and warnings before use keep the carton. It contains important information. store at 20° - 25°C (68° - 77°F) protect from moisture" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide" ], "questions": [ "Questions or comments? 1-800-755-4008 (toll-free) or 215-273-8755 (collect)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton AC Famotidine Tablets 20 mg Acid Reducer Just One Tablet! Prevents & Relieves Heartburn Due to Acid Indigestion [tablet image] 5 Tablets [Lil' Drug Store® logo] PDP/Package" ], "set_id": "14406cd8-468b-403d-9be2-43decd304214", "id": "0e8487fc-3e0e-bbfc-e063-6394a90a3073", "effective_time": "20240109", "version": "7", "openfda": { "application_number": [ "NDA020325" ], "brand_name": [ "Pepcid AC" ], "generic_name": [ "FAMOTIDINE" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-9748" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FAMOTIDINE" ], "rxcui": [ "104094", "310273" ], "spl_id": [ "0e8487fc-3e0e-bbfc-e063-6394a90a3073" ], "spl_set_id": [ "14406cd8-468b-403d-9be2-43decd304214" ], "package_ndc": [ "66715-9748-8" ], "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" ] } } ] }