Childrens SUDAFED PE Cold and Cough

Dosage form: solution
Ingredients: Dextromethorphan hydrobromide 5mg in 5mL, Phenylephrine hydrochloride 2.5mg in 5mL
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-785

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 Cold and Cough

Drug Facts

Active ingredients (in each 5 mL)Purpose
5 mL = one teaspoon
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCl 2.5 mgNasal decongestant

Use
  • temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
    • cough
    • nasal congestion

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
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
  • 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
  • cough gets worse or lasts for more than 7 days
  • cough tends to come back or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

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
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours
  • do not give more than 6 times in 24 hours.
Age (yr)Dose (tsp)
under 4 yearsdo not use
4 to 5 years1 teaspoonful (5 mL)
6 to 11 years2 teaspoonfuls (10 mL)

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

Other information
  • each teaspoon contains: sodium 15 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 blue #1, 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 50580-785-04

NON-DROWSY
children's
SUDAFED PE
®
COLD &
COUGH

Sinus Pressure
& Stuffy Nose
Phenylephrine HCl
Cough
Dextromethorphan
HBr

Grape
Flavor Liquid
Alcohol & Sugar Free

4 fl oz (118 mL)

CHILDRENS SUDAFED PE COLD AND COUGH 
dextromethorphan hydrobromide and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-785
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan hydrobromide (dextromethorphan) Dextromethorphan hydrobromide5 mg  in 5 mL
Phenylephrine hydrochloride (phenylephrine) Phenylephrine hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
carboxymethylcellulose sodium 
edetate disodium 
FD&C blue NO. 1 
FD&C red NO. 40 
glycerin 
water 
sodium benzoate 
sodium citrate 
sorbitol 
sucralose 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-785-041 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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