RANITIDINE

Wockhardt Limited

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 eating or drinking 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

Ask a doctor before use if you have

• frequent wheezing, particularly with heartburn       
• frequent chest pain       
• stomach pain
• unexplained weight loss                                         
• nausea or vomiting          
• 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:55648-740 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE RANITIDINE 75 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline CROSCARMELLOSE SODIUM MAGNESIUM STEARATE COLLOIDAL SILICON DIOXIDE ferric oxide red titanium dioxide diethyl phthalate HYPROMELLOSES Product Characteristics Color Size Imprint Code Shape pink (Pink colored film coated) 8 mm W;75 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:55648-740-05 10000 in 1 POUCH 6 NDC:55648-740-00 60000 in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078884 2008-07-31