NDC Code(s) : 0406-8553-50
Packager : Mallinckrodt, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0406-8553
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE5 mg in 5 mL
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
CORN SYRUP(UNII: 9G5L16BK6N)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
WATER(UNII: 059QF0KO0R)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Product Characteristics
Color RED (clear red) Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0406-8553-50500 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040680 03/10/2011

PRINCIPAL DISPLAY PANEL

NDC 0406-8553-50

Oxycodone Hydrochloride and  Acetaminophen
Oral Solution

CII

5 mg/325 mg per 5 mL

Each 5 mL contains:
Oxycodone Hydrochloride USP ..... 5mg*
Acetaminophen USP ................. 325 mg
Sucrose-Free
(*5 mg Oxycodone HCl is equivalent to 4.4815 mg Oxycodone)

Rx only

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

500 mL

Mallinckrodt™

L00O37     Rev 12/2016

Principal Display Panel