Label: ACID REDUCER 150- ranitidine hydrochloride tablets 150mg tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 21130-404-02, 21130-404-34, 21130-404-50 - Packager: Safeway Inc
- This is a repackaged label.
- Source NDC Code(s): 55111-404
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 30, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use(s)
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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
- if you have kidney disease, except under the advice and supervision of a doctor
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
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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
- Questions
- container label
- CARTON LABELING - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACID REDUCER 150
ranitidine hydrochloride tablets 150mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-404(NDC:55111-404) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 150 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score no score Shape ROUND Size 9mm Flavor Imprint Code R150 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-404-34 1 in 1 CARTON 05/14/2012 09/30/2019 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:21130-404-50 1 in 1 CARTON 05/14/2012 09/30/2019 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:21130-404-02 1 in 1 CARTON 05/14/2012 09/30/2019 3 200 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 ANDA078192 05/14/2012 Labeler - Safeway Inc (009137209)