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RANITIDINE by WOCKHARDT LIMITED

Dosage form: tablet, coated
Ingredients: RANITIDINE HYDROCHLORIDE 150mg
Labeler: WOCKHARDT LIMITED
NDC Code: 55648-741

Drug Facts

Active ingredient (in each tablet) Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Purpose Acid reducer

Uses
  • 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

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
  • 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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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
  • 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

Inactive Ingredients colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD and C yellow # 6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.

Questions or comments?
Call 1-800-346-6854

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Manufactured by:
Wockhardt Limited,
Mumbai, India.

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Rev.151111



RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-741
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
COLLOIDAL SILICON DIOXIDE 
HYPROMELLOSES 
FD&C YELLOW NO. 6 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
DIETHYL PHTHALATE 
Product Characteristics
Colororange (orange colored film coated) Scoreno score
ShapeHEXAGON (6 sided)Size10mm
FlavorImprint CodeW741
Contains    
Packaging
#Item CodePackage Description
1NDC:55648-741-011 BOTTLE (BOTTLE) in 1 CARTON
110 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:55648-741-021 BOTTLE (BOTTLE) in 1 CARTON
2100 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:55648-741-051 BOTTLE (BOTTLE) in 1 CARTON
3500 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:55648-741-0310 BLISTER PACK (BLISTER PACK) in 1 CARTON
410 TABLET, COATED (TABLET) in 1 BLISTER PACK
5NDC:55648-741-066000 TABLET, COATED (TABLET) in 1 POUCH
6NDC:55648-741-0030000 TABLET, COATED (TABLET) in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07865311/26/2007
Labeler - WOCKHARDT LIMITED (650069115)
Establishment
NameAddressID/FEIOperations
WOCKHARDT LIMITED676257570manufacture

 
WOCKHARDT LIMITED

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Medically reviewed on Nov 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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