Label: RANITIDINE tablet
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NDC Code(s):
55111-131-04,
55111-131-14,
55111-131-30,
55111-131-37, view more55111-131-45, 55111-131-60, 55111-131-79, 55111-131-80, 55111-131-81, 55111-131-90
- Packager: Dr. Reddy's Laboratories Limited
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 2, 2019
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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 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
- kidney disease
Ask a doctor or pharmacist before use if you are
• taking a prescription drug. Acid reducers may interact with certain prescription drugs.
- if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
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Directions
- adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water
- to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
- do not chew tablet
- children under 12 years: ask a doctor
- adults and children 12 years and over:
- Other information
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RANITIDINE
ranitidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-131 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 HYPROMELLOSES (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) ferrosoferric oxide (UNII: XM0M87F357) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score no score Shape ROUND Size 7mm Flavor Imprint Code P75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55111-131-30 1 in 1 CARTON 03/01/2000 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55111-131-60 1 in 1 CARTON 03/01/2000 2 60 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:55111-131-80 1 in 1 CARTON 03/01/2000 3 80 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:55111-131-90 1 in 1 CARTON 03/01/2000 4 90 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:55111-131-04 1 in 1 CARTON 03/01/2000 5 120 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:55111-131-37 1 in 1 CARTON 03/01/2000 6 160 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:55111-131-79 1 in 1 CARTON 03/01/2000 7 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:55111-131-14 2 in 1 CARTON 03/01/2000 8 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:55111-131-81 3 in 1 CARTON 03/01/2000 9 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:55111-131-45 1 in 1 CARTON 03/01/2000 10 45 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 ANDA075294 03/01/2000 Labeler - Dr. Reddy's Laboratories Limited (650562841)