CHILDRENS SUDAFED PE  NASAL DECONGESTANT- phenylephrine hydrochloride solution 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Childrens Sudafed PE
NASAL DECONGESTANT

Drug Facts

Active ingredient (in each 5 mL)

Phenylephrine HCl 2.5 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
  • a sodium-restricted diet

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, carboxymethylcellulose sodium, edetate disodium, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-784-04

children's
SUDAFED®
PE

non-drowsy

NASAL
DECONGESTANT

Phenylephrine HCl Oral Solution
Nasal Decongestant

RELIEF OF

Stuffy Nose
Sinus Pressure

Berry
FLAVOR LIQUID
ALCOHOL &
SUGAR FREE

4 fl oz (118 mL) 2.5 mg per 5 mL

PRINCIPAL DISPLAY PANEL
CHILDRENS SUDAFED PE   NASAL DECONGESTANT
phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-784
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
edetate disodium (UNII: 7FLD91C86K)  
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
ColorREDScore    
ShapeSize
FlavorRASPBERRY (BERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-784-041 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 FINALpart34110/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 3/2021
Document Id: 49041770-7e7d-4470-8f64-acd9ade50d04
Set id: 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d
Version: 8
Effective Time: 20210301
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division