Label: FAMOTIDINE tablet
Contains inactivated NDC Code(s)
NDC Code(s): 55648-374-00, 55648-374-01, 55648-374-05, 55648-374-07, view more55648-374-08, 55648-374-09
- Packager: WOCKHARDT LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 7, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablets)
Allergy alert: Do not use if you are allergic to famotidine or other acid reducersDo not use
Ask a doctor before use if you have
- 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
Stop use and ask a doctor 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
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- 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 ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55648-374 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) STARCH, CORN (UNII: O8232NY3SJ) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color white (white) Score no score Shape ROUND (barrel shaped) Size 9mm Flavor Imprint Code W374 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55648-374-01 1 in 1 CARTON 1 30 in 1 BOTTLE 2 NDC:55648-374-08 1 in 1 CARTON 2 30 in 1 BOTTLE 3 NDC:55648-374-05 1 in 1 CARTON 3 500 in 1 BOTTLE 4 NDC:55648-374-07 10 in 1 CARTON 4 10 in 1 BLISTER PACK 5 NDC:55648-374-00 38000 in 1 DRUM 6 NDC:55648-374-09 6500 in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090837 08/06/2010 Labeler - WOCKHARDT LIMITED (650069115)