Label: RANITIDINE- ranitidine hydrochloride tablet, film coated
- NDC Code(s): 60505-2880-7
- Packager: Apotex Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 12, 2016
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- Active ingredient (in each tablet)
Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 mg)
- 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 any 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.
- 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
- adults and children 12 years and over:
- Other information
- do not use if printed foil under bottle cap is broken or torn
- store at 20°C to 25°C (68°F to 77°F)
- avoid excessive heat or humidity
- this product is sodium and sugar free
- Inactive ingredients
carnauba wax, colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and vanillinClose
- Questions or Comments?
Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time)
- Principal Display Panel
Ranitidine Tablets USP, 150 mg 10,000 ct bottle
Prevents & Relieves
Heartburn Associated with Acid Indigestion & Sour Stomach
Distributed by: Apotex Corp. Weston, Florida 33326, USA.
- INGREDIENTS AND APPEARANCE
ranitidine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-2880 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 Carnauba Wax (UNII: R12CBM0EIZ) Silicon Dioxide (UNII: ETJ7Z6XBU4) Hypromelloses (UNII: 3NXW29V3WO) Magnesium Stearate (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) Polydextrose (UNII: VH2XOU12IE) Titanium Dioxide (UNII: 15FIX9V2JP) Vanillin (UNII: CHI530446X) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Product Characteristics Color PINK Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60505-2880-7 10000 in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200172 07/15/2013 Labeler - Apotex Corp. (845263701) Registrant - Apotex Inc. (209429182) Establishment Name Address ID/FEI Business Operations Apotex Inc 209429182 manufacture(60505-2880) , analysis(60505-2880)