Label: RANITIDINE tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 64679-740-00, 64679-740-01, 64679-740-02, 64679-740-03, view more64679-740-04, 64679-740-05 - Packager: Wockhardt USA LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 6, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- USAGE
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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
ASK A DOCTOR BEFORE USE IF YOU HAVE
o frequent wheezing, particularly with heartburn
o frequent chest pain
o stomach pain
o unexplained weight loss
o nausea or vomiting
o had heartburn over 3 months. This may be a sign of a more serious condition.
o heartburn with lightheadedness, sweating or dizziness.
o 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
o your heartburn continues or worsens
o you need to take this product for more than 14 days
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
- OTC - KEEP OUT OF REACH OF CHILDREN
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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
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RANITIDINE
ranitidine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-740 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIETHYL PHTHALATE (UNII: UF064M00AF) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (Pink colored film coated) Score no score Shape HEXAGON (6 SIDED) Size 8mm Flavor Imprint Code W;75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64679-740-01 1 in 1 CARTON 07/31/2008 1 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:64679-740-02 1 in 1 CARTON 07/31/2008 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:64679-740-04 1 in 1 CARTON 07/31/2008 3 500 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:64679-740-03 10 in 1 CARTON 07/31/2008 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:64679-740-05 10000 in 1 POUCH; Type 0: Not a Combination Product 07/31/2008 6 NDC:64679-740-00 60000 in 1 DRUM; Type 0: Not a Combination Product 07/31/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078884 07/31/2008 Labeler - Wockhardt USA LLC. (170508365) Registrant - Wockhardt Limited (650069115) Establishment Name Address ID/FEI Business Operations Wockhardt Limited 676257570 ANALYSIS(64679-740) , LABEL(64679-740) , MANUFACTURE(64679-740) , PACK(64679-740)
