Label: FAMOTIDINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 64679-374-00, 64679-374-01, 64679-374-05, 64679-374-07, view more64679-374-08, 64679-374-09 - Packager: Wockhardt USA LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 26, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- USES
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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.
● if you have kidney disease, except under the advice and supervision of a 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
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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 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 INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-374 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 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) Product Characteristics Color WHITE (white) Score no score Shape ROUND Size 9mm Flavor Imprint Code W374 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64679-374-01 1 in 1 CARTON 08/06/2010 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:64679-374-08 1 in 1 CARTON 08/06/2010 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:64679-374-05 1 in 1 CARTON 08/06/2010 3 500 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:64679-374-07 10 in 1 CARTON 08/06/2010 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:64679-374-00 38000 in 1 DRUM; Type 0: Not a Combination Product 08/06/2010 6 NDC:64679-374-09 6500 in 1 DRUM; Type 0: Not a Combination Product 08/06/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090837 08/06/2010 Labeler - Wockhardt USA LLC. (170508365) Registrant - Wockhardt Limited (650069115) Establishment Name Address ID/FEI Business Operations Wockhardt Limited 916489953 ANALYSIS(64679-374) , LABEL(64679-374) , MANUFACTURE(64679-374) , PACK(64679-374)
