Label: WAL-ZAN 75- ranitidine tablet usp, 75mg tablet
- NDC Code(s): 0363-0131-30, 0363-0131-33, 0363-0131-80
- Packager: Walgreens Company
- 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.
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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
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- 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
- 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)
- children under 12 years: ask a doctor
- adults and children 12 years and over:
- Other information
- Inactive ingredients
- Question Section
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
WAL-ZAN 75
ranitidine tablet usp, 75mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0131(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:0363-0131-30 1 in 1 CARTON 01/06/2014 09/30/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0131-80 1 in 1 CARTON 01/06/2014 09/30/2019 2 80 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-0131-33 1 in 1 CARTON 01/06/2014 09/30/2019 3 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 01/06/2014 Labeler - Walgreens Company (008965063)