RANITIDINE- ranitidine hydrochloride tablet, film coated 
Apotex Corp.


Drug Facts

Active ingredient (in each tablet)

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



Acid reducer



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
  • if you have kidney disease, except under the advice 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 healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away


Other information

Inactive ingredients

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


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 - Bottle Label - 10,000 Tablets

Acid Reducer

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

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


ranitidine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-2880
Route of Administration ORAL
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)  
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
# 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 07/15/2013
2 NDC:60505-2880-0 3 in 1 CARTON 07/15/2013
2 8 in 1 BLISTER PACK; 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)
Name Address ID/FEI Business Operations
Apotex Inc 209429182 manufacture(60505-2880) , analysis(60505-2880)

Revised: 6/2017
Document Id: 9464c42a-a015-d648-1e93-98db26f4115d
Set id: c816755c-055e-8cbc-9c7a-d794cda2d74b
Version: 9
Effective Time: 20170606
Apotex Corp.