NDC Code(s) : 0121-1781-05, 0121-1781-00
Packager : PAI Holdings, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens AcetaminophenAcetaminophen SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1781
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color red Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0121-1781-0010 in 1 CASE 17/09/2007
110 in 1 TRAY
1NDC:0121-1781-055 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 09/17/2007

LABELER - PAI Holdings, LLC(044940096)

Establishment
Name Address ID/FEI Business Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 097630693 manufacture(0121-1781)

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-1781-05

CHILDREN'S ACETAMINOPHEN  ORAL SUSPENSION

160 mg per 5 mL

Ibuprofen Free/ Alcohol Free / Aspirin Free

SHAKE WELL BEFORE USING

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

5 mL Unit Dose Cup Label