{"active_ingredient":["Active ingredient (in each tablet) Famotidine, USP 10 mg and 20 mg"],"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."],"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"],"dosage_and_administration":["Directions • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn o to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn o before eating food or drinking beverages that cause heartburn o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor"],"effective_time":"20260113","id":"5502899d-30bd-4954-8aae-9ab1c034f65f","inactive_ingredient":["Inactive ingredients Hydroxypropyl Cellulose, Hypromellose, , Macrogol, Magnesium stearate, Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Talc, Triacetin, Titanium dioxide"],"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"],"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."],"openfda":{"application_number":["ANDA215822"],"brand_name":["Famotidine"],"generic_name":["FAMOTIDINE"],"is_original_packager":[true],"manufacturer_name":["GLENMARK THERAPEUTICS INC., USA"],"nui":["N0000000151","N0000175784"],"package_ndc":["72657-112-90","72657-112-20","72657-113-88","72657-113-20","72657-132-01"],"pharm_class_epc":["Histamine-2 Receptor Antagonist [EPC]"],"pharm_class_moa":["Histamine H2 Receptor Antagonists [MoA]"],"product_ndc":["72657-112","72657-113","72657-132"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["199047","310273"],"spl_id":["5502899d-30bd-4954-8aae-9ab1c034f65f"],"spl_set_id":["95f51f27-d367-4cfd-a15f-7856c9e361fb"],"substance_name":["FAMOTIDINE"],"unii":["5QZO15J2Z8"],"upc":["0372657132015","0372657112901","0372657113885"]},"package_label_principal_display_panel":["Principal Display Panel NDC 72657-112-90 Famotidine Tablets, USP 10mg 90 Tablets carton10mg90","Principal Display Panel NDC 72657-113-88 Famotidine Tablets, USP 20mg 85 Tablets carton20mg85","Principal Display Panel NDC 72657-132-01 Famotidine Tablets, USP 20mg 100 Tablets carton20mg100"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Acid reducer"],"questions":["Questions or comments? Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115. Do not use if printed foil seal on bottle is broken or missing. JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. TIPS FOR MANAGING HEARTBURN 􀀁 Do not lie flat or bend over after eating 􀀁 Do not wear tight-fitting clothing around the stomach 􀀁 Do not eat before bedtime 􀀁 Raise the head of your bed 􀀁 Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables 􀀁 Eat slowly and avoid big meals 􀀁 If overweight, lose weight 􀀁 Quit smoking"],"set_id":"95f51f27-d367-4cfd-a15f-7856c9e361fb","spl_product_data_elements":["Famotidine Famotidine MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A HYDROXYPROPYL CELLULOSE (110000 WAMW) MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE TRIACETIN POLYETHYLENE GLYCOL 4000 TALC FAMOTIDINE FAMOTIDINE white to off-white V;21 Famotidine Famotidine MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A HYDROXYPROPYL CELLULOSE (110000 WAMW) MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE TRIACETIN POLYETHYLENE GLYCOL 4000 TALC FAMOTIDINE FAMOTIDINE white to off-white V;15 Famotidine Famotidine MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A HYDROXYPROPYL CELLULOSE (110000 WAMW) MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE TRIACETIN POLYETHYLENE GLYCOL 4000 TALC FAMOTIDINE FAMOTIDINE white to off-white V;15"],"spl_unclassified_section":["Drug Facts","Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 Made in India M.L. No.: 02/SKL/AP/2015/F/R Revision: 07/25"],"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"],"storage_and_handling":["Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20°C to 25°C (68°F to 77°F) • protect from moisture"],"version":"4","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."]}