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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-473
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 75 mg
Inactive Ingredients
Ingredient Name Strength
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
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code OR;606
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-473-12 1 in 1 CARTON
1 60 in 1 BOTTLE
2 NDC:49348-473-44 1 in 1 CARTON
2 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201745 09/20/2013
Labeler - Sunmark (177667227)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Shasun Pharmaceuticals Limited 915786829 manufacture(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