Drugplain

Childrens SUDAFED PE Cold plus Cough 5 mg/5mL

Dextromethorphan hydrobromide and Phenylephrine hydrochloride · SOLUTION · Kenvue Brands LLC

No Recall History
Plain English

Childrens SUDAFED PE Cold plus Cough is a solution containing dextromethorphan hydrobromide and phenylephrine hydrochloride at 5 mg/5mL, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Childrens SUDAFED PE Cold plus Cough
Generic Name
Dextromethorphan hydrobromide and Phenylephrine hydrochloride
NDC Code (Product)
50580-785
Manufacturer
Kenvue Brands LLC
Strength
5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
10/01/2008

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: cough nasal congestion sinus congestion and pressure

Dosage & Administration

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.

Warnings

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)

Frequently Asked Questions

What is Childrens SUDAFED PE Cold plus Cough used for?

Childrens SUDAFED PE Cold plus Cough contains Dextromethorphan hydrobromide and Phenylephrine hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is Childrens SUDAFED PE Cold plus Cough a controlled substance?

Childrens SUDAFED PE Cold plus Cough is not classified as a controlled substance by the DEA.

What is the generic name for Childrens SUDAFED PE Cold plus Cough?

The generic name for Childrens SUDAFED PE Cold plus Cough is Dextromethorphan hydrobromide and Phenylephrine hydrochloride. There are no other listed brand versions of Dextromethorphan hydrobromide and Phenylephrine hydrochloride.

What is the NDC code for Childrens SUDAFED PE Cold plus Cough 5 mg/5mL?

The NDC (National Drug Code) for Childrens SUDAFED PE Cold plus Cough 5 mg/5mL is 50580-785, listed by Kenvue Brands LLC.

Product NDC

50580-785

Package NDC

50580-785-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)