Childrens Sudafed PE NASAL DECONGESTANT

Dosage form: solution
Ingredients: Phenylephrine hydrochloride 2.5mg in 5mL
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-784

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.

Childrens Sudafed PE
NASAL DECONGESTANT

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Phenylephrine HCl 2.5 mg

Purpose

Nasal decongestant

Use

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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
  • find right dose on chart below
  • mL = milliliter; tsp = teaspoonful
  • repeat dose every 4 hours
  • do not use more than 6 times in 24 hours
Age (yr)Dose (mL or tsp)
under 4 yearsdo not use
4 to 5 years5 mL (1 tsp)
6 to 11 years10 mL (2 tsp)

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

Other information
  • each 5 mL (1 tsp) contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
  • do not use if bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

NDC 50580-784-04

NON-DROWSY
children's
SUDAFED PE
®
NASAL
DECONGESTANT

Phenylephrine HCl oral solution
Nasal decongestant

Sinus Pressure
& Stuffy Nose
Phenylephrine HCl

Due to Colds
& Allergies

Raspberry
Flavor Liquid
Alcohol &
Sugar Free

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

CHILDRENS SUDAFED PE   NASAL DECONGESTANT
phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-784
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine hydrochloride (phenylephrine) Phenylephrine hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
carboxymethylcellulose sodium 
edetate disodium 
FD&C red No. 40 
glycerin 
water 
sodium benzoate 
sodium citrate 
sorbitol 
sucralose 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-784-041 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2008
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 10/2011
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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