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FDA LABEL GENERIC: Pseudoephedrine MFR: Kenvue Brands LLC

Pseudoephedrine Hcl 15 Mg In 5 Ml Oral Solution

Drug Facts

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

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

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

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