PARNATE- tranylcypromine sulfate tablet, film coated 
GlaxoSmithKline Inc

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PARNATE
(tranylcypromine sulfate)
tablets 10 mg

PRINCIPAL DISPLAY PANEL

Parnate Bottle Label

Bottle Label

NDC 24987-447-10                    100 Tablets

Parnate®
(tranylcypromine sulfate)
Tablets

10 mg

Federal Law requires dispensing of PARNATE® with the Medication Guide under this label.

Rx only

COVIS

Store tablets between 15o and 30oC (59o and 86oF). Dispense in a tight, light-resistant container. Each tablet contains tranylcypromine, 10 mg, as the sulfate.

Usual Dosage: 30 mg per day, usually given in divided doses. See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Dist. by Covis Pharmaceuticals, Inc.
Cary, NC 27511
Mfd. by GlaxoSmithKline
Mississauga, ON, Canada L5N 6L4

Made in Italy                  100025                   Rev. 5/12

A 1 0 3 4 3 5

PARNATE 
tranylcypromine sulfate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-036
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRANYLCYPROMINE SULFATE (UNII: 7ZAT6ES870) (TRANYLCYPROMINE - UNII:3E3V44J4Z9) TRANYLCYPROMINE10 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (rose-red) Scoreno score
ShapeROUNDSize4mm
FlavorImprint Code PARNATE;SB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-036-00100 in 1 BOTTLE; Type 0: Not a Combination Product01/14/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA01234201/14/2013
Labeler - GlaxoSmithKline Inc (205556368)
Establishment
NameAddressID/FEIBusiness Operations
GlaxoSmithKline Inc205556368MANUFACTURE(53873-036)

Revised: 12/2017
Document Id: 59a1946d-f291-4086-b162-d56848ea4367
Set id: c9f8288e-60af-431a-a370-a6096d15b3e9
Version: 2
Effective Time: 20171208
 
GlaxoSmithKline Inc