Label: ACID REDUCER- ranitidine tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 61715-090-30 - Packager: Preferred Plus (Kinray)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 15, 2020
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
- •
- 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
-
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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACID REDUCER
ranitidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-090 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color pink Score no score Shape ROUND Size 8mm Flavor Imprint Code OR;606 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-090-30 3 in 1 CARTON 01/15/2020 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201745 01/27/2014 Labeler - Preferred Plus (Kinray) (012574513) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Shasun Pharmaceuticals Limited 915786829 MANUFACTURE(61715-090)