Label: REGULAR STRENGTH ACID REDUCER- ranitidine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55319-352-30 - Packager: Family Dollar
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2014
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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 ranitidine or any other acid reducers.
Do not use
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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.
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- with other acid reducers
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
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- to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutesbefore eating food or drinking beverages that cause heartburn
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- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
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- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
FAMILY
wellnessCOMPARE TO THE ACTIVE INGREDIENT OF ZANTAC 75® TABLETS*
Regular Strength
Acid Reducer
Ranitidine Tablets USP, 75 mgPrevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach
30 TABLETS
MADE IN INDIA
DISTRIBUTED BY
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA5110364 0614
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
Family Wellness
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INGREDIENTS AND APPEARANCE
REGULAR STRENGTH ACID REDUCER
ranitidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-352 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 75 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code OR;606 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-352-30 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201745 09/24/2013 Labeler - Family Dollar (024472631) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Shasun Pharmaceuticals Limited 915786829 API MANUFACTURE(55319-352)