Label: ACID REDUCER- ranitidine tablet
- Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 22, 2016
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- ACTIVE INGREDIENT (IN EACH TABLET)
Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)Close
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
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 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
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
- store at 20° - 25° C (68° - 77° F)
- avoid excessive heat or humidity
- this product is sodium and sugar free
- INACTIVE INGREDIENTS
Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxideClose
- PRINCIPAL DISPLAY PANEL
†Compare To the active ingredient of Zantac 150®
Ranitidine Tablets, USP 150 mg
- Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-351 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color pink Score no score Shape OVAL Size 12mm Flavor Imprint Code 9R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-351-24 24 in 1 CARTON 03/30/2012 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51660-351-50 1 in 1 CARTON 03/30/2012 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:51660-351-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2012 4 NDC:51660-351-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2014 5 NDC:51660-351-66 65 in 1 BOTTLE; Type 0: Not a Combination Product 04/23/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200536 06/28/2011 Labeler - Ohm Laboratories Inc. (184769029) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Shasun Pharmaceuticals Limited 915786829 MANUFACTURE(51660-351)