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Drug Facts
Childrens Sudafed Pe Cold Plus Cough Solution
FDA Label NDC 50580-785
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Childrens Sudafed Pe Cold Plus Cough (NDC 50580-785). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
Otc - 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.
Otc - Ask Doctor
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
Otc - When Using
When using this product do not exceed recommended dose
Otc - Stop Use
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.
Otc - 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
- 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 bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" 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)
Principal Display Panel (Sudafed 01)
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