Label: MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH- famotidine tablet, film coated
- NDC Code(s): 0904-5780-17, 0904-5780-51
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 21, 2021
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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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- 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.
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- with other acid reducers
Ask a doctor before use if you have
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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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- 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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- kidney disease
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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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 or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5780 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code L194 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5780-51 1 in 1 CARTON 09/29/2006 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0904-5780-17 25 in 1 CARTON 10/04/2006 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077351 09/29/2006 Labeler - Major Pharmaceuticals (191427277)