Label: FAMOTIDINE - ACID CONTROLLER- famotidine tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 51660-036-26 - Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 16, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
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WARNINGS
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do not use
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- with other acid reducers
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- if you have kidney disease, except under the advice and supervision of a doctor.
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- 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
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- frequent chest pain
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- heartburn with lightheadedness, sweating, or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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DIRECTIONS
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- adults and children 12 years and over:
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- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
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- 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
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- do not use more than 2 tablets in 24 hours
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- children under 12 years: ask a doctor
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OTHER INFORMATION
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- store at 20° to 25° C (68° to 77° F)
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- protect from moisture
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- read the directions and warnings before use
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- keep the carton. It contains important information.
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- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (for blister carton)
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- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for bottle carton/label)
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- TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for SAL/extended label)
- INACTIVE INGREDIENTS
- QUESTIONS?
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PATIENT INFORMATION
JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
See end panel for batch number and expiration date. (for carton only)
Tips for Managing Heartburn
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- Do not lie flat or bend over after eating
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- Do not wear tight-fitting clothing around the stomach
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- Do not eat before bedtime
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- Raise the head of your bed
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- Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
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- Eat slowly and avoid big meals
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- If overweight, lose weight
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- Quit smoking
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Principal Display Panel
†Compare to the active ingredient of Maximum Strength Pepcid AC®.
NDC 51660-036-26
ohm®
MAXIMUM STRENGTH
Acid Controller
Famotidine Tablets, USP 20 mg
Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion
25 TABLETS
Distributed by: Ohm Laboratories Inc.
5142565/R0517
25's Blister Carton
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INGREDIENTS AND APPEARANCE
FAMOTIDINE - ACID CONTROLLER
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-036 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 (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) 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 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:51660-036-26 25 in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090283 05/31/2017 Labeler - Ohm Laboratories Inc. (184769029) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(51660-036)
