RANITIDINE- ranitidine hydrochloride tablet, film coated 
Aphena Pharma Solutions - Tennessee, LLC

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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) 

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count150mg
18043353-952-80
100043353-952-71

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20160602DH

Principal Display Panel

Maximum Strength

Ranitidine Tablets USP, 150 mg 180 & 1000 ct bottle

Acid Reducer

Prevents & Relieves

Heartburn Associated with Acid Indigestion & Sour Stomach

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

PRINCIPAL DISPLAY PANEL - 150mg

NDC 43353-952 - Ranitidine HCl 150mg - Rx Only
Bottle Label 150mg

RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-952(NDC:60505-2880)
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)  
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
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43353-952-80180 in 1 BOTTLE; Type 0: Not a Combination Product06/26/2014
2NDC:43353-952-711000 in 1 BOTTLE; Type 0: Not a Combination Product06/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20017207/15/2013
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-952)

Revised: 6/2016
Document Id: 1d958be7-19f4-4ad9-929c-409a037bda20
Set id: 48d5c94c-4806-4b69-92d1-a0fc09ef9c96
Version: 1
Effective Time: 20160601
 
Aphena Pharma Solutions - Tennessee, LLC