RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride tablet, film coated 
Select Brand

----------

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

NDC 15127-711-30

select brand®

Regular Strength

Ranitidine Tablets, USP 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Compare to the active ingredient of Zantac 75®

30 Tablets

Distributed by: SELECT BRAND® DISTRIBUTORS

5094996/0412

This is the 30 count bottle carton label for Select Brand Ranitidine tablets, USP 75 mg.
RANITIDINE HYDROCHLORIDE 
ranitidine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-711
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:15127-711-30 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201745 07/10/2012
Labeler - Select Brand (043562370)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
Name Address ID/FEI Business Operations
Shasun Pharmaceuticals Limited 915786829 manufacture(15127-711)

Revised: 9/2012
Document Id: 2b36b3a0-e2a7-4db3-ba87-965e7c8f3086
Set id: ab60994a-9e23-4779-a05b-d708d57228b3
Version: 1
Effective Time: 20120928
 
Select Brand