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Ranitidine 75 by Major Pharmaceuticals

Dosage form: tablet
Ingredients: RANITIDINE HYDROCHLORIDE 75mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5818

Major Pharmaceuticals Ranitidine 75 Tablets Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 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 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 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
  • do not use if printed foil under cap is broken or missing
  • 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, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

Questions or comments?

1-800-719-9260

Principal Display Panel

Ranitidine 75

Ranitidine Tablets, 75 mg

Acid Reducer

One Tablet Relieves and Prevents:

Heartburn Associated with Acid Indigestion and Sour Stomach

Compare to the active ingredient of Zantac 75®

# Doses {Replace "#" with number tablets in package}

Ranitidine 75 Tablets Carton

RANITIDINE 75 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5818
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE75 mg
Product Characteristics
ColorPINKScoreno score
ShapeHEXAGON (6 sided)Size8mm
FlavorImprint CodeW75
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5818-461 BOTTLE (BOTTLE) in 1 CARTON
130 TABLET (TABLET) in 1 BOTTLE
2NDC:0904-5818-521 BOTTLE (BOTTLE) in 1 CARTON
260 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07676005/26/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 07/2009
 
Major Pharmaceuticals

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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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