Childrens SUDAFED PE Cold plus Cough
Dextromethorphan hydrobromide and Phenylephrine hydrochloride · Solution · Oral
Active ingredient
Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant
Purpose
Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant
Uses
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
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)
Do not use
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
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
When using this product do not exceed recommended dose
Stop use and ask a doctor
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
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
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
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
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?
Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Label text from the FDA structured product label by Kenvue Brands LLC (revised Nov 12, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dextromethorphan Hydrobromide in 1 product
- Phenylephrine Hydrochloride in 1 product
Childrens SUDAFED PE Cold plus Cough NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50580-785 | Dextromethorphan Hydrobromide 5 mg/5mL; Phenylephrine Hydrochloride 2.5 mg/5mL Solution | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Childrens SUDAFED PE Cold plus Cough used for?
Uses temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: cough nasal congestion sinus congestion and pressure
Who makes Childrens SUDAFED PE Cold plus Cough?
Childrens SUDAFED PE Cold plus Cough is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.