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RANITIDINE by WOCKHARDT USA LLC.

Medically reviewed on April 2, 2018

Dosage form: tablet, coated
Ingredients: RANITIDINE HYDROCHLORIDE 75mg
Labeler: WOCKHARDT USA LLC.
NDC Code: 64679-740

Drug Facts

Active ingredient (in each tablet)                                                                        Purpose
Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)..................................................Acid reducer

Uses
  • 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

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
  • 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

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 ingredientscolloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, 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.

Iss.020410

RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-740
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE HYDROCHLORIDE75 mg
Product Characteristics
Colorpink (Pink colored film coated) Scoreno score
ShapeHEXAGON (6 sided)Size8mm
FlavorImprint CodeW;75
Contains    
Packaging
#Item CodePackage Description
1NDC:64679-740-011 BOTTLE (BOTTLE) in 1 CARTON
110 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:64679-740-021 BOTTLE (BOTTLE) in 1 CARTON
2100 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:64679-740-041 BOTTLE (BOTTLE) in 1 CARTON
3500 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:64679-740-0310 BLISTER PACK (BLISTER PACK) in 1 CARTON
410 TABLET, COATED (TABLET) in 1 BLISTER PACK
5NDC:64679-740-0510000 TABLET, COATED (TABLET) in 1 POUCH
6NDC:64679-740-0060000 TABLET, COATED (TABLET) in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07888407/31/2008
Labeler - WOCKHARDT USA LLC. (170508365)

 
WOCKHARDT USA LLC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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