![FAMOTIDINE TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]](https://medic.hrt.org//dailymed/images/1e6cebc6-a79a-405e-9824-197534a8b08b/famotidine-01.jpg)
![FAMOTIDINE TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]](https://medic.hrt.org//dailymed/images/1e6cebc6-a79a-405e-9824-197534a8b08b/famotidine-02.jpg)
| NDC | 63868-486-25, 63868-486-50, 63868-714-30 |
| Set ID | 1e6cebc6-a79a-405e-9824-197534a8b08b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Chain Drug Marketing Association Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA090283 |
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
-
WARNINGS
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do not use
- with other acid reducers
- 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
- if you have kidney disease, except under the advice and supervision of a doctor.
- 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.
Ask a doctor before use if you have
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- 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
-
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
- 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 to60 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
- adults and children 12 years and over:
-
OTHER INFORMATION
- store at 20° to 25°C (68° to 77°F)
- protect from moisture
- read the directions and warnings before use
- keep the carton. It contains important information.
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
- INACTIVE INGREDIENTS
- QUESTIONS?
-
PATIENT INFORMATION
- 1 tablet relieves heartburn due to acid indigestion
- Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
- Do not lie flat or bend over after eating
- Do not wear tight-fitting clothing around the stomach
- Do not eat before bedtime
- Raise the head of your bed
- Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
- Eat slowly and avoid big meals
- If overweight, lose weight
- Quit smoking
- PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
- PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
-
INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-714 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape ROUND Size 8mm Flavor Imprint Code 035 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-714-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 06/25/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090283 06/25/2010 FAMOTIDINE
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-486 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code 036 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-486-25 25 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2010 2 NDC:63868-486-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090283 07/23/2010 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(63868-714, 63868-486)
