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Ranitidine by Apotex Corp.

Medically reviewed on June 6, 2017

Dosage form: tablet, film coated
Ingredients: Ranitidine Hydrochloride 75mg
Labeler: Apotex Corp.
NDC Code: 60505-2881

Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 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 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
  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

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)
    • do not chew tablet
  • children under 12 years: ask a doctor

Other information
  • do not use if seal under bottle cap is broken or torn
  • store at 20°C to 25°C (68°F to 77°F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide

Questions?

Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time)

Principal Display Panel- Bottle Carton - 75 mg 30 Tablets

Regular Strength

Ranitidine Tablets USP, 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Distributed by: Apotex Corp. Weston, Florida 33326, USA.

Principal Display Panel- Blister Carton - 75 mg 30 Tablets

Regular Strength

Ranitidine Tablets USP, 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Distributed by: Apotex Corp. Weston, Florida 33326, USA.

RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-2881
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ranitidine Hydrochloride (Ranitidine) Ranitidine75 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax 
Silicon Dioxide 
Hypromelloses 
Magnesium Stearate 
Cellulose, Microcrystalline 
Polydextrose 
Titanium Dioxide 
Vanillin 
Ferric Oxide Red 
Ferric Oxide Yellow 
Product Characteristics
ColorPINKScoreno score
ShapePENTAGON (5 sided)Size8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60505-2881-31 BOTTLE in 1 CARTON
130 TABLET, FILM COATED in 1 BOTTLE
2NDC:60505-2881-81 BOTTLE in 1 CARTON
280 TABLET, FILM COATED in 1 BOTTLE
3NDC:60505-2881-71 BOTTLE in 1 CARTON
31000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07516701/24/2005
RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-0160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ranitidine Hydrochloride (Ranitidine) Ranitidine75 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax 
Silicon Dioxide 
Hypromelloses 
Magnesium Stearate 
Cellulose, Microcrystalline 
Polydextrose 
Titanium Dioxide 
Vanillin 
Ferric Oxide Red 
Ferric Oxide Yellow 
Product Characteristics
ColorPINKScoreno score
ShapePENTAGON (5 sided)Size8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60505-0160-31 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:60505-0160-43 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07516712/22/2016
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Apotex Inc.209429182manufacture(60505-2881, 60505-0160), analysis(60505-2881, 60505-0160)

 
Apotex Corp.

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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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