NDC Code(s) : 50580-170-01, 50580-170-03, 50580-170-02, 50580-170-04
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:50580-170
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
WATER(UNII: 059QF0KO0R)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
GLYCERIN(UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Product Characteristics
Color white Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50580-170-011 in 1 CARTON 16/01/2017
1120 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
2NDC:50580-170-032 in 1 PACKAGE 10/01/2020
21 in 1 CARTON 16/01/2017
2120 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
3NDC:50580-170-021 in 1 CARTON 06/01/2021
3240 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
4NDC:50580-170-043 in 1 PACKAGE 06/01/2021
41 in 1 CARTON 06/01/2021
4120 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 50580-170-02

Children's
TYLENOL ®

Acetaminophen (160 mg per 5 mL)
Oral Suspension

Pain Reliever-Fever Reducer

DYE-FREE

Pain + Fever

Ages 2-11 Years

Free of:

  • Dyes
  • Alcohol
  • Ibuprofen
  • Aspirin
  • Parabens
  • High Fructose

Corn Syrup

Cherry Flavor

8 fl oz (240 mL)
160 mg per 5 mL

tylenol-01