Label: MAXIMUM STRENGTH ACID CONTROLLER- famotidine tablet
- NDC Code(s): 21130-027-05
- Packager: BETTER LIVING BRANDS LLC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 30, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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DOSAGE & 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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH ACID CONTROLLER
famotidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-027 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 TALC (UNII: 7SEV7J4R1U) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape SEMI-CIRCLE (D-shaped) Size 9mm Flavor Imprint Code 87 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-027-05 1 in 1 CARTON 06/23/2023 1 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 ANDA217543 06/23/2023 Labeler - BETTER LIVING BRANDS LLC. (009137209) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(21130-027)