NDC Code(s) : 50580-785-04
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens SUDAFED PE Cold plus CoughDextromethorphan hydrobromide and Phenylephrine hydrochloride SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-785
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE5 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE2.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color purple Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50580-785-041 in 1 CARTON 10/01/2008
1118 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 M012 10/01/2008

LABELER - Johnson & Johnson Consumer Inc.(878046358)

Establishment
Name Address ID/FEI Business Operations
Siegfried PharmaChemikalien Minden Gmbh 328153106 api manufacture(50580-785)

PRINCIPAL DISPLAY PANEL

NDC 50580-785-04

children's
SUDAFED ®
PE

non-drowsy
COLD + COUGH

Phenylephrine HCl • Dextromethorphan HBr
Nasal Decongestant • Cough Suppressant
Oral Solution

RELIEF OF

  • Stuffy Nose
  • Sinus Pressure
  • Cough

Grape
FLAVOR LIQUID
ALCOHOL &
SUGAR FREE

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL