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Ranitidine Hydrochloride by Dr. Reddy's Laboratories Limited

Dosage form: tablet, coated
Ingredients: Ranitidine Hydrochloride 168mg
Labeler: Dr. Reddy's Laboratories Limited
NDC Code: 55111-404

Drug Facts

Active ingredient(s)

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 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
  • 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 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 sugar free

Inactive ingredients

FD&C red 40, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide

Questions

call 1-888-375-3784

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR  PROTECTION.

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

CARTON LABELING - PRINCIPAL DISPLAY PANEL

Carton :

RANITIDINE HYDROCHLORIDE 
ranitidine hydrochloride 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) Ranitidine Hydrochloride168 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 (BOTTLE) in 1 CARTON
124 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:55111-404-501 BOTTLE (BOTTLE) in 1 CARTON
250 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:55111-404-611 BOTTLE (BOTTLE) in 1 CARTON
365 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:55111-404-621 BOTTLE (BOTTLE) in 1 CARTON
495 TABLET, COATED (TABLET) in 1 BOTTLE
5NDC:55111-404-171 BLISTER PACK (BLISTER PACK) in 1 CARTON
58 TABLET, COATED (TABLET) in 1 BLISTER PACK
6NDC:55111-404-243 BLISTER PACK (BLISTER PACK) in 1 CARTON
68 TABLET, COATED (TABLET) in 1 BLISTER PACK
7NDC:55111-404-384 BLISTER PACK (BLISTER PACK) in 1 CARTON
78 TABLET, COATED (TABLET) 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: 10/2011
 
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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