CHILDRENS SUDAFED NASAL DECONGESTANT- pseudoephedrine hydrochloride solution 
Kenvue Brands LLC

----------

Children's Sudafed

Nasal Decongestant

Drug Facts

Active ingredient (in each 5 mL)

Pseudoephedrine HCl 15 mg

Purpose

Nasal decongestant

Uses

Warnings

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

When using this product do not exceed recommended dose

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Age (yr)Dose (mL)
under 4 yearsdo not use
4 to 5 years5 mL
6 to 11 years10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, poloxamer 407, polyethylene glycol, povidone K-90, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-536-04

children's
SUDAFED ®

non-drowsy

NASAL
DECONGESTANT

Pseudoephedrine HCl Oral Solution
Nasal Decongestant

RELIEF OF

Grape
FLAVOR LIQUID
ALCOHOL &
SUGAR FREE

4 fl oz (118 mL) 15 mg per 5 mL

Principal Display Panel
CHILDRENS SUDAFED  NASAL DECONGESTANT
pseudoephedrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-536
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-536-041 in 1 CARTON10/01/2008
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/01/2008
Labeler - Kenvue Brands LLC (118772437)

Revised: 11/2024
Document Id: 21732f4a-40b0-b486-e063-6394a90a1536
Set id: 52e9307b-ad38-4f65-bb2f-4fa262e82010
Version: 9
Effective Time: 20241108
 
Kenvue Brands LLC