Label: RANITIDINE- ranitidine hydrochloride tablet, film coated
- NDC Code(s): 49035-353-30, 49035-353-55, 49035-353-69
- Packager: Wal-Mart Stores, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT (IN EACH TABLET)
Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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
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
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 400, talc, titanium dioxideClose
- PRINCIPAL DISPLAY PANEL
Compare to Zantac 75®Active Ingredient*
Ranitidine Tablets, 75 mg
- Prevents and Relieves Heartburn associated with acid indigestion and sour stomach
Distributed by: Wal-Mart Stores, Inc.,
- INGREDIENTS AND APPEARANCE
ranitidine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-353 Route of Administration ORAL DEA Schedule 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) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:49035-353-55 150 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-353-69 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:49035-353-30 30 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 ANDA201745 07/10/2012 Labeler - Wal-Mart Stores, Inc (051957769) Registrant - Ranbaxy Pharmaceuticals Inc. (184769029) Establishment Name Address ID/FEI Business Operations Shasun Pharmaceuticals Limited 915786829 MANUFACTURE(49035-353)