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Childrens SUDAFED PE Cold plus Cough

Dosage form
SOLUTION
Labeler
Kenvue Brands LLC
Label updated
2024-11-12
Retrieved
2026-09-07
Active ingredients
DEXTROMETHORPHAN HYDROBROMIDE · PHENYLEPHRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

유효 성분

성분·작용

Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal decongestant
Uses
  • temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
    • cough
    • nasal congestion
    • sinus congestion and pressure
Warnings

Label information

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.

Label information

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

Label information

When using this product do not exceed recommended dose

Label information

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.

Label information

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 = milliliters
  • repeat dose every 4 hours
  • do not give more than 6 times in 24 hours
Age (yr) Dose (mL)
under 4 years do not use
4 to 5 years 5 mL
6 to 11 years 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 5 mL 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 carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue no. 1, 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 50580-785-04

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)

[Image in the official label — see DailyMed source]

DailyMed Set ID: 20e45243-3989-413a-bcf1-49d754ff2e44 · Version 12
NDC: 50580-785