Ranitidine Tablet USP, 150 mg

Drug Labeling and Warnings

Drug Details [pdf]

RANITIDINE- ranitidine tablet 
Shasun Pharmaceuticals Limited

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Ranitidine Tablet USP, 150 mg

SPL UNCLASSIFIED

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS AND USAGE

  • 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

OTC - 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.

OTC - ASK DOCTOR

  • 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

OTC - STOP USE

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

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

STORAGE AND HANDLING

  • 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 INGREDIENT

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

OTC - QUESTIONS

call 1-800-406-7984

SPL UNCLASSIFIED

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

label
RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 57910-404
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorPINKScoreno score
ShapeOVAL (Oval Shaped) Size12mm
FlavorImprint Code RX;828
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 57910-404-331 in 1 BOX06/28/201109/08/2019
16000 in 1 BAG; Type 0: Not a Combination Product
2NDC: 57910-404-32600 in 1 BAG; Type 0: Not a Combination Product06/28/201109/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20053606/28/201109/08/2019
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Strides Shasun Limited (915786829)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited915786829MANUFACTURE(57910-404)

Revised: 9/2019