Label: ZANTAC 150- ranitidine tablet
- NDC Code(s): 50269-220-25
- Packager: JC World Bell Wholesale Co., Inc.
- Category: HUMAN OTC DRUG LABEL
Updated December 18, 2017
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- Drug Facts
- Active ingredient (in each tablet)
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
- had hertburn 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
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- 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
- Other information
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50269-220 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 HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color orange Score no score Shape PENTAGON (5 sided) Size 7mm Flavor Imprint Code Z;150 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50269-220-25 25 in 1 BOX 07/29/2016 1 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021698 07/29/2016 Labeler - JC World Bell Wholesale Co., Inc. (805257581)