RANITIDINE- ranitidine hydrochloride tablet, film coated 
Apotex Corp.

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Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 mg)

                                 

Purpose

Acid reducer

Uses

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or any 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
  • if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

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.

Directions

Other information

Inactive ingredients

carnauba wax, colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and vanillin

Questions or Comments?

Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) 

Principal Display Panel

Maximum Strength

Ranitidine Tablets USP, 150 mg 10,000 ct bottle

Acid Reducer

Prevents & Relieves

Heartburn Associated with Acid Indigestion & Sour Stomach

Distributed by: Apotex Corp. Weston, Florida 33326, USA.

ranitidine-150mg-otc-lbl

RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-2880
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ranitidine Hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine 150 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax (UNII: R12CBM0EIZ)  
Colloidal Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polydextrose (UNII: VH2XOU12IE)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Vanillin (UNII: CHI530446X)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60505-2880-7 10000 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200172 07/15/2013
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Business Operations
Apotex Inc 209429182 manufacture(60505-2880) , analysis(60505-2880)

Revised: 8/2015
Document Id: b7739a90-c121-c55a-7417-80c78c13c8b5
Set id: c816755c-055e-8cbc-9c7a-d794cda2d74b
Version: 6
Effective Time: 20150812
 
Apotex Corp.