RANITIDINE- ranitidine tablet 
Shasun Pharmaceuticals Limited

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RANITIDINE

SPL UNCLASSIFIED

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 75 mg (as ranitidine hydrochloride 84 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 eating or drinking certain foods and beverages

WARNINGS

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

OTC - 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

OTC - ASK DOCTOR

  • 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

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

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

STORAGE AND HANDLING

●    Blister: do not use if individual blister 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 stearate, microcrystalline cellulose, polyethylene glycol 400, 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:57910-405
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code OR;606
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57910-405-3412000 in 1 BAG; Type 0: Not a Combination Product02/29/201209/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174502/29/201209/08/2019
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Strides Shasun Limited (915786829)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited915786829MANUFACTURE(57910-405)

Revised: 9/2019
 
Shasun Pharmaceuticals Limited