RANITIDINE

Wockhardt Limited

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Do not use
• Ask a doctor before use if you have
• Stop use and ask a doctor if

FULL PRESCRIBING INFORMATION

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

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

• 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

• 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

• Blister: do not use if individual unit is open or torn 
  Bottle: do not use if printed foil under bottle cap is open or torn
• store at 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• this product is sugar free

RANITIDINE RANITIDINE TABLET, COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:55648-741 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE RANITIDINE 150 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline CROSCARMELLOSE SODIUM MAGNESIUM STEARATE COLLOIDAL SILICON DIOXIDE HYPROMELLOSES FD&C YELLOW NO. 6 ferric oxide red titanium dioxide diethyl phthalate Product Characteristics Color Size Imprint Code Shape orange (orange colored film coated) 10 mm W741 HEXAGON (6 sided) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 in 1 BOTTLE 2 100 in 1 BOTTLE 3 500 in 1 BOTTLE 4 10 in 1 BLISTER PACK 5 NDC:55648-741-06 6000 in 1 POUCH 6 NDC:55648-741-00 30000 in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078653 2007-11-26