Label: RANITIDINE tablet
- NDC Code(s): 0904-6921-46, 0904-6921-52
- Packager: MAJOR PHARMACEUTICALS
- This is a repackaged label.
- Source NDC Code(s): 55111-131
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 30, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- 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.
-
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?
- Bottle label
- Carton label
-
INGREDIENTS AND APPEARANCE
RANITIDINE
ranitidine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6921(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:0904-6921-46 1 in 1 CARTON 05/28/2019 09/30/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0904-6921-52 1 in 1 CARTON 05/28/2019 09/30/2019 2 60 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 05/28/2019 Labeler - MAJOR PHARMACEUTICALS (191427277)