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Drug Facts
Childrens Sudafed Solution
FDA Label NDC 50580-536
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 (NDC 50580-536). 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, active ingredient (in each 5 ml), purpose, uses, otc - do not use, ask a doctor before use if the child has, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
Pseudoephedrine HCl 15 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- promotes nasal and/or sinus drainage
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.
Ask A Doctor Before Use If The Child Has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Otc - When Using
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
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 = milliliter
- repeat dose every 4 to 6 hours
- do not use more than 4 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 5 mg
- store between 20-25°C (68-77°F)
- do not use if bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, poloxamer 407, polyethylene glycol, povidone K-90, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution
Questions Or Comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-536-04
children's
SUDAFED®
non-drowsy
NASAL
DECONGESTANT
Pseudoephedrine HCl Oral Solution
Nasal Decongestant
RELIEF OF
✔ Stuffy Nose✔ Sinus Pressure
Grape
FLAVOR LIQUID
ALCOHOL &
SUGAR FREE
4 fl oz (118 mL) 15 mg per 5 mL
Principal Display Panel (Sudafed 01)
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