NDC Code(s) : 50580-509-01
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens TYLENOLAcetaminophen SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-509
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
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color red Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50580-509-011 in 1 CARTON 16/01/2017
1120 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 01/16/2017

LABELER - Johnson & Johnson Consumer Inc.(878046358)

PRINCIPAL DISPLAY PANEL

NDC 50580-509-01

Children's
TYLENOL ®

Acetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

No Parabens
Ibuprofen Free
Alcohol Free
Aspirin Free

4 fl oz (120 mL)
160 mg per 5 mL

Strawberry
Flavor

Principal Display Panel