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RANITIDINE by Aurohealth LLC

Dosage form: tablet, film coated
Ingredients: RANITIDINE HYDROCHLORIDE 75mg
Labeler: Aurohealth LLC
NDC Code: 58602-733

Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride USP 83.707 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
  • 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 (1-800-222-1222) 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
  • TAMPER EVIDENT: Do Not Use If The Carton Or Printed Foil Under Cap Is Open or Torn.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free
  • USP Dissolution Test pending.

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin

Questions?

call 1-855-274-4122

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

Consumer Information

What you should know about
Regular Strength
Ranitidine Tablets USP, 75 mg

ACID REDUCER

(Please read all of this information before taking ranitidine tablets 75 mg. Save this leaflet for future reference.)

What are ranitidine tablets 75 mg?
 

  • Ranitidine tablets 75 mg contain 75 mg of ranitidine (as ranitidine hydrochloride USP, 83.707 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

Excellent Safety Record


  • Ranitidine tablets 75 mg have been used safely and effectively for years as an over-the-counter medication.
  • Ranitidine tablets 75 mg are sugar free.

What symptoms do ranitidine tablets 75 mg relieve and prevent?


  • Ranitidine tablets 75 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.

Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion or sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.



How should I take ranitidine tablets 75 mg?


  • 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.

This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).

  • Do not chew tablet

Ranitidine tablets 75 mg should not be given to children under 12 years old unless directed by a doctor.
 

  • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

How do ranitidine tablets 75 mg work?


  • Ranitidine tablets 75 mg reduce the production of stomach acid. This is what makes ranitidine tablets 75 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

Additional tips for managing heartburn

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night, or just before bedtime
  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
  • Eat slowly and do not eat big meals
  • If you are overweight, lose weight
  • If you smoke, quit smoking
  • Raise the head of your bed
  • Wear loose fitting clothing around your stomach

Clinical studies prove ranitidine tablets 75 mg are effective in relieving ….


In clinical studies, ranitidine tablets 75 mg
were significantly better than placebo pills.



…. and preventing heart burn.

 

  • 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

When should I see a doctor? 

  • 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 healthcare professional before use. 
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions? Call 1-855-274-4122

BOTTLES: Do Not Use If The Printed Foil Under Cap Is Open or Torn.

BLISTERS: Do Not Use If The Carton Or Individual Blister Unit Is Open or Torn.

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

Revised: 11/2017 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (30 Tablets Bottle)

AUROHEALTH

NDC 58602-733-09

Regular Strength


Ranitidine
Tablets USP,
75 mg

ACID
REDUCER

PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach

30 TABLETS (30 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (30 Tablets Container Carton )

AUROHEALTH
*Compare to the active
ingredient in Zantac 75®

NDC 58602-733-09

Regular Strength

Ranitidine
Tablets USP,
75 mg

ACID
REDUCER

PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach

30 TABLETS (30 DOSES
)





RANITIDINE 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-733
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2910 (5 MPA.S) 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeK;42
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-733-091 BOTTLE in 1 CARTON
130 TABLET, FILM COATED in 1 BOTTLE
2NDC:58602-733-151 BOTTLE in 1 CARTON
260 TABLET, FILM COATED in 1 BOTTLE
3NDC:58602-733-181 BOTTLE in 1 CARTON
380 TABLET, FILM COATED in 1 BOTTLE
4NDC:58602-733-221 BOTTLE in 1 CARTON
4105 TABLET, FILM COATED in 1 BOTTLE
5NDC:58602-733-231 BOTTLE in 1 CARTON
5120 TABLET, FILM COATED in 1 BOTTLE
6NDC:58602-733-301 BOTTLE in 1 CARTON
6160 TABLET, FILM COATED in 1 BOTTLE
7NDC:58602-733-401 BOTTLE in 1 CARTON
7500 TABLET, FILM COATED in 1 BOTTLE
8NDC:58602-733-031 BLISTER PACK in 1 CARTON
810 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20757911/13/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(58602-733), MANUFACTURE(58602-733)
Establishment
NameAddressID/FEIOperations
Saraca Laboratories Limited650443851API MANUFACTURE(58602-733)

 
Aurohealth LLC

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Medically reviewed on Jun 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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