RANITIDINE- ranitidine tablet, film coated 
Amerisource Bergen

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

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

PURPOSE

Acid reducer

USES

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

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 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 (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY

Compare to active ingredient in Zantac 75®

NDC 46122-0223-72

Regular Strength

Acid Reducer

Ranitidine Tablets, USP 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

60 Tablets

Distributed By AmerisourceBergen

5103697/0613

60's bottle carton label
RANITIDINE 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL 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:46122-223-651 in 1 CARTON
130 in 1 BOTTLE
2NDC:46122-223-721 in 1 CARTON
260 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174509/06/2013
Labeler - Amerisource Bergen (007914906)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829manufacture(46122-223)

Revised: 7/2013
Document Id: ace6f559-73e4-4853-a71f-5d3b7cb96031
Set id: 113d3844-0dfa-4ccf-852d-5a0559e52bcd
Version: 1
Effective Time: 20130708
 
Amerisource Bergen