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

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

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
  • 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

  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water
    • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
    • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
    • do not chew tablet
  • children under 12 years: ask a doctor

Other information

  • do not use if individual blister unit is open or torn
  • store at 20°C to 25°C (68°F to 77°F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

carnauba wax, colloidal silicon dioxide, cool vanilla mint flavor, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide

Questions or Comments?

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

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., distributor of Zantac 150® Cool Mint Tablets. Zantac 150® is a registered trademark of Boehringer Ingelheim Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 150 mg 24s BLISTER CARTON

Maximum Strength

Ranitidine Tablets USP, 150 mg (Cool Mint Tablets)

Acid Reducer

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Releases a Cooling Sensation in Mouth & Throat

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

ranitidine-150-cool-mint-24ct
RANITIDINE  
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4623
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ranitidine Hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax (UNII: R12CBM0EIZ)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Polydextrose (UNII: VH2XOU12IE)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize9mm
FlavorMINTImprint Code APO;RAN;150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-4623-21 in 1 CARTON07/27/201710/31/2019
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:60505-4623-51 in 1 CARTON07/27/201710/31/2020
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:60505-4623-61 in 1 CARTON07/27/201710/31/2020
365 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:60505-4623-91 in 1 CARTON07/27/201710/31/2020
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:60505-4623-81000 in 1 BOTTLE; Type 0: Not a Combination Product07/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20017207/27/201710/31/2020
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.209429182analysis(60505-4623) , manufacture(60505-4623)

Revised: 11/2019
Document Id: 79026753-b4f6-b094-f0f3-156492d41412
Set id: b44ad5ae-28a9-3e44-c3a9-abde56308361
Version: 4
Effective Time: 20191119
 
Apotex Corp.