RANITIDINE- ranitidine tablet, film coated 
REMEDYREPACK INC.

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Drug Facts

OTC - ACTIVE INGREDIENT

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)

 

OTC - PURPOSE

Acid reducer

 

INDICATIONS & 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

 

  • 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

 

  • 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

 

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

 

ask a health professional before use.

 

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

 

DOSAGE & 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)
  • children under 12 years: ask a doctor

 

STORAGE AND HANDLING

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER 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

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Ranitidine


GENERIC: Ranitidine


DOSAGE: TABLET, FILM COATED


ADMINSTRATION: ORAL


NDC: 61786-214-02


ACTIVE INGREDIENT(S):

  • RANITIDINE HYDROCHLORIDE 75mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POLYETHYLENE GLYCOL 400
  • MAGNESIUM STEARATE
  • TALC
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • FERRIC OXIDE RED
  • HYPROMELLOSES
  • TITANIUM DIOXIDE


COLOR: pink


SHAPE: ROUND


SCORE: No score


SIZE: 8 mm


IMPRINT: OR;606


PACKAGING: 30 in 1 BOTTLE


OUTER PACKAGING: 1 BOTTLE in 1 CARTON




MM1

MM2

RANITIDINE 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-214(NDC:0904-6349)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUND (TABLET, FILM COATED) Size8mm
FlavorImprint Code OR;606
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-214-021 in 1 CARTON03/10/201503/15/2017
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174503/10/201503/15/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.