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Ranitidine by P and L Development of New York Corporation

Dosage form: tablet
Ingredients: RANITIDINE HYDROCHLORIDE 75mg
Labeler: P and L Development of New York Corporation
NDC Code: 59726-580

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 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
  • 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?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Zantac 75®

Ranitidine Tablets USP, 75 mg

Acid Reducer

Prevents and relieves:

Heartburn associated with acid indigestion and sour stomach

10 Tablets

10 Doses

* This product is not manufactured or distributed by Boehringer Ingelheim Consumer health care products, owner of the registered trademark Zantac 75®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF PRINTED FOIL UNDER BOTTLE CAP IS OPEN OR TORN

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

Distributed by:

PL Developments

200 Hicks street

Westbury NY 11590

PRODUCT OF INDIA

Product Label

Ranitidine 75 mg

RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-580
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
DIETHYL PHTHALATE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeHEXAGON (6 SIDED)Size8mm
FlavorImprint CodeW;75
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-580-101 BOTTLE (1 BOTTLE) in 1 BOX
110 TABLET (10 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07888403/19/2013
Labeler - P and L Development of New York Corporation (800014821)
Registrant - P and L Development of New York Corporation (800014821)

 
P and L Development of New York Corporation

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Medically reviewed on Apr 5, 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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