Label: FAMOTIDINE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 37808-036-26, 37808-036-50 - Packager: HEB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 7, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
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WARNINGS
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do not use
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- with other acid reducers
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- if you have kidney disease, except under the advice and supervision of a doctor
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- 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.
Ask a doctor before use if you have
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- frequent chest pain
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- heartburn with lightheadedness, sweating, or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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DIRECTIONS
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- adults and children 12 years and over:
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- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
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- 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
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- do not use more than 2 tablets in 24 hours
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- children under 12 years: ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
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PATIENT INFORMATION
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- JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
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- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
Tips for Managing Heartburn
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- Do not lie flat or bend over after eating
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- Do not wear tight-fitting clothing around the stomach
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- Do not eat before bedtime
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- Raise the head of your bed
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- Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
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- Eat slowly and avoid big meals
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- If overweight, lose weight
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- Quit smoking
- PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-036 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code 036 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-036-26 1 in 1 CARTON 04/09/2014 1 25 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:37808-036-50 1 in 1 CARTON 04/09/2014 2 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090283 04/09/2014 Labeler - HEB (007924756) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(37808-036)
