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Ranitidine by Shasun Pharmaceuticals Limited

Dosage form: tablet
Ingredients: RANITIDINE HYDROCHLORIDE 150mg
Labeler: Shasun Pharmaceuticals Limited
NDC Code: 57910-404

Ranitidine Tablet USP, 150 mg

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 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 certain foods and beverages

Warnings

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

Do not use
  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor
  • 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.

Ask a doctor before use if you have
  • nausea or vomiting
  • stomach pain
  • unexplained weight loss
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • 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)

          ○ do not chew tablet

• children under 12 years: ask a doctor

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

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearte, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions?

call 1-800-406-7984

IMPORTANT

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

Distributed by: Ohm Laboratories Inc, 1385 Livingston Avenue, North Brunsluick, NJ 08902

MADE IN INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57910-404
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeOVAL (Oval Shaped) Size12mm
FlavorImprint CodeRX;828
Contains    
Packaging
#Item CodePackage Description
1NDC:57910-404-32600 TABLET (TABLET) in 1 BAG
2NDC:57910-404-331 BAG (BAG) in 1 BOX
26000 TABLET (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20053606/28/2011
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Shasun Pharmaceuticals Limited (915786829)
Establishment
NameAddressID/FEIOperations
Shasun Pharmaceuticals Limited915786829Manufacture

 
Shasun Pharmaceuticals Limited

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Medically reviewed on Sep 27, 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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