Label: ACID REDUCER MAXIMUM STRENGTH- famotodine tablet
- NDC Code(s): 69168-443-09, 69168-443-32, 69168-443-50, 69168-443-52
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 16, 2024
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- Active ingredient(s)
- Purpose
- Use(s)
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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
- 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.
- if you have trouble or pain swallowing food, vomiting with blood, or bloody
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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 15 to 60 minutes before eating food or drinking beverages that
cause heartburn n do not use more than 2 tablets in 24 hours
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions/Comments
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ACID REDUCER MAXIMUM STRENGTH
famotodine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-443 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 HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code V;15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-443-32 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2024 2 NDC:69168-443-52 225 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2024 3 NDC:69168-443-09 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 02/29/2024 4 NDC:69168-443-50 1 in 1 CARTON 03/05/2024 4 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 ANDA215822 01/15/2024 Labeler - Allegiant Health (079501930)