Nucynta (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NUCYNTA^™
(tapentadol) Tablets

50 mg

CII

Each tablet contains:

tapentadol 50 mg

Caution: Federal law prohibits the transfer
of this drug to any person other than the patient
for whom it was prescribed.

Please see the Medication Guide provided by your pharmacist.

NUCYNTA^™
(tapentadol) Tablets

75 mg

CII

Each tablet contains:

tapentadol 75 mg

Caution: Federal law prohibits the transfer
of this drug to any person other than the patientfor whom it was prescribed.

Please see the Medication Guide

NUCYNTA^™
(tapentadol) Tablets

100 mg

CII

Each tablet contains:

tapentadol 100 mg

Caution: Federal law prohibits the transfer
of this drug to any person other than the patient
for whom it was prescribed.

Please see the Medication Guide provided by your pharmacist.

NUCYNTA tapentadol hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5979(NDC:50458-820) Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM POVIDONE MAGNESIUM STEARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL TALC ALUMINUM OXIDE

Product Characteristics Color yellow Score no score Shape ROUND (round and biconvex) Size 7mm Flavor Imprint Code O;M;50 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-5979-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None 2 NDC:54868-5979-1 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022304 03/19/2010

NUCYNTA tapentadol hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6002(NDC:50458-830) Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL HYDROCHLORIDE 75 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM POVIDONE MAGNESIUM STEARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL TALC ALUMINUM OXIDE

Product Characteristics Color yellow (yellow orange) Score no score Shape ROUND (round and bioxonvex) Size 8mm Flavor Imprint Code O;M;75 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-6002-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022304 03/19/2010

NUCYNTA tapentadol hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6039(NDC:50458-840) Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM POVIDONE MAGNESIUM STEARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL TALC ALUMINUM OXIDE

Product Characteristics Color orange Score no score Shape ROUND (round and biconvex) Size 9mm Flavor Imprint Code O;M;100 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-6039-0 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022304 03/19/2010

Labeler — Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.