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Ranitidine by Dr. Reddy's Laboratories Limited

Dosage form: tablet
Ingredients: ranitidine hydrochloride 75mg
Labeler: Dr. Reddy's Laboratories Limited
NDC Code: 55111-131

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 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

  • this product is sodium and sugar free
  • Blister: do not use if individual blister unit is open or torn
    Bottle: do not use if printed foil under bottle cap is open or torn
  • avoid excessive heat or humidity
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions? call 1-888-375-3784

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

Package Label Principal Display Panel

Ranitidine Tablets USP, 75 mg - Blister Carton Label

Ranitidine Tablets USP, 75 mg - container label

Ranitidine Tablets USP, 75 mg - Container carton label

RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-131
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ranitidine hydrochloride (ranitidine) ranitidine75 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
magnesium stearate 
cellulose, microcrystalline 
Polyethylene Glycols 
ferrosoferric oxide 
titanium dioxide 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeP75
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-131-241 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
2NDC:55111-131-301 BOTTLE in 1 CARTON
230 TABLET in 1 BOTTLE
3NDC:55111-131-601 BOTTLE in 1 CARTON
360 TABLET in 1 BOTTLE
4NDC:55111-131-801 BOTTLE in 1 CARTON
480 TABLET in 1 BOTTLE
5NDC:55111-131-901 BOTTLE in 1 CARTON
590 TABLET in 1 BOTTLE
6NDC:55111-131-041 BOTTLE in 1 CARTON
6120 TABLET in 1 BOTTLE
7NDC:55111-131-371 BOTTLE in 1 CARTON
7160 TABLET in 1 BOTTLE
8NDC:55111-131-791 BLISTER PACK in 1 CARTON
810 TABLET in 1 BLISTER PACK
9NDC:55111-131-142 BLISTER PACK in 1 CARTON
910 TABLET in 1 BLISTER PACK
10NDC:55111-131-813 BLISTER PACK in 1 CARTON
1010 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07529403/01/2000
Labeler - Dr. Reddy's Laboratories Limited (650562841)

Revised: 06/2013
 
Dr. Reddy's Laboratories Limited

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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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