Label: FAMOTIDINE ORIGINAL STRENGTH- famotidine tablet
- NDC Code(s): 49035-128-90
- Packager: EQUATE (Walmart Stores, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 7, 2013
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- Active ingredient (in each tablet)
Famotidine USP 10 mgClose
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 15 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
- adults and children 12 years and over:
- Other information
- read the directions and warnings before use
- store at 25°-30°C (77°-86°F)
- protect from moisture
- Inactive ingredients
hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Pepcid® AC® Active Ingredient*
Famotidine Tablets, 10 mg
- Just one tablet prevents and relieves heartburn due to acid indigestion
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Tips for Managing Heartburn
- 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
Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716 ©Wal-mart Stores, Inc.
Product of India
*This product is not manufactured or distributed by © McNeil Consumer Pharmaceuticals Co., owner of the registered trademark Pepcid® AC®.Close
- Product label
Famotidine Tablets 10 mg
- INGREDIENTS AND APPEARANCE
FAMOTIDINE ORIGINAL STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-128 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 HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (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 W;972 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-128-90 1 in 1 BOX 1 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077146 12/18/2012 Labeler - EQUATE (Walmart Stores, Inc.) (051957769) Registrant - P and L Development of New York Corporation (800014821)