Label: FAMOTIDINE tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 64679-972-00, 64679-972-01, 64679-972-02, 64679-972-03 - Packager: Wockhardt USA LLC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 26, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- USES
-
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
Stop use and ask a doctor if
● your heartburn continues or worsens
● you need to take this product for more than 14 days
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
- OTC - KEEP OUT OF REACH OF CHILDREN
-
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 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 INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-972 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color PINK (pink) Score no score Shape ROUND Size 8mm Flavor Imprint Code W;972 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64679-972-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2005 2 NDC:64679-972-02 10 in 1 CARTON 03/07/2005 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:64679-972-00 50000 in 1 DRUM; Type 0: Not a Combination Product 03/07/2005 4 NDC:64679-972-03 40000 in 1 DRUM; Type 0: Not a Combination Product 03/07/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077146 03/07/2005 Labeler - Wockhardt USA LLC. (170508365) Registrant - Wockhardt Limited (650069115) Establishment Name Address ID/FEI Business Operations Wockhardt Limited 916489953 ANALYSIS(64679-972) , LABEL(64679-972) , MANUFACTURE(64679-972) , PACK(64679-972)
