RANITIDINE- ranitidine hydrochloride tablet, film coated 
Sunmark

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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

sunmark®

*COMPARE TO ZANTAC 75® ACTIVE INGREDIENT

NDC 49348-473-12

Ranitidine Tablets, USP 75 mg

acid reducer

Prevents and Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Regular Strength

60 TABLETS

Distributed By McKesson

5104148/0713

60's bottle carton label

RANITIDINE 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-473
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code OR;606
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-473-121 in 1 CARTON
160 in 1 BOTTLE
2NDC:49348-473-441 in 1 CARTON
230 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174509/20/2013
Labeler - Sunmark (177667227)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829manufacture(49348-473)

Revised: 8/2013
Document Id: 7b32dc8d-59e9-4772-8f66-7b22a7b73688
Set id: 840a3114-7b29-40f4-b076-376b94f98146
Version: 1
Effective Time: 20130812
 
Sunmark