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Ranitidine by Dr. Reddy's Laboratories Limited

Dosage form: tablet, coated
Ingredients: Ranitidine Hydrochloride 150mg
Labeler: Dr. Reddy's Laboratories Limited
NDC Code: 55111-404

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Purpose

Acid reducer

Use(s)

  • 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
  • if you have kidney disease, except under the advice and supervision of 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 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 bottle cap is open or torn
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat or humidity
  • protect from light
  • this product is sodium and sugar free

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

Consumer Information

What you should know about

MAXIMUM STRENGTH

Ranitidine Tablets USP, 150 mg

(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride USP, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

Excellent Safety Record

  • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications.
  • MAXIMUM STRENGTH Ranitidne Tablets USP, 150 mg are sodium and sugar free.

What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent heartburn associated with acid Indigestion and sour stomach. Eating or drinking certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal to 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 MAXIMUM STRENGTH Ranitidine Tablets USP, 150 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 (up to 2 tablets in 24 hours).

  • Do not chew tablet.

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 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 does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduce the production of stomach acid. This is what make MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

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

When should I see a doctor?

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
  • if you have kidney disease, except under the advice and supervision of 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.
  • heartbrun 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.

Questions? Call 1-888-375-3784

BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.

BLISTERS: Do not use if the individual blister unit is open or torn.

Consumer Information

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION. IMPORTANT:

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Container Label:

Container Carton Label:

Blister Carton Label:

RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-404
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ranitidine Hydrochloride (RANITIDINE) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
HYPROMELLOSE 2910 (6 MPA.S) 
FERROSOFERRIC OXIDE 
magnesium stearate 
cellulose, microcrystalline 
POLYETHYLENE GLYCOL 400 
titanium dioxide 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeR150
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-404-341 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
2NDC:55111-404-321 BOTTLE in 1 CARTON
232 TABLET, COATED in 1 BOTTLE
3NDC:55111-404-501 BOTTLE in 1 CARTON
350 TABLET, COATED in 1 BOTTLE
4NDC:55111-404-611 BOTTLE in 1 CARTON
465 TABLET, COATED in 1 BOTTLE
5NDC:55111-404-621 BOTTLE in 1 CARTON
595 TABLET, COATED in 1 BOTTLE
6NDC:55111-404-021 BOTTLE in 1 CARTON
6200 TABLET, COATED in 1 BOTTLE
7NDC:55111-404-651 BOTTLE in 1 CARTON
7220 TABLET, COATED in 1 BOTTLE
8NDC:55111-404-171 BLISTER PACK in 1 CARTON
88 TABLET, COATED in 1 BLISTER PACK
9NDC:55111-404-243 BLISTER PACK in 1 CARTON
98 TABLET, COATED in 1 BLISTER PACK
10NDC:55111-404-384 BLISTER PACK in 1 CARTON
108 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07819212/02/2009
Labeler - Dr. Reddy's Laboratories Limited (650562841)

Revised: 09/2015
 
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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