Childrens Sudafed PE

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Childrens Sudafed PE NASAL DECONGESTANT

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL = 1 teaspoonful)
• Purpose
• Use
• Warnings
  • Ask a doctor before use if the child has
  • Stop use and ask a doctor if
• Directions
• Childrens Sudafed PE Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Phenylephrine HCl 2.5 mg

Purpose

Nasal decongestant

Use

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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
• 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

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; tsp = teaspoonful
• repeat dose every 4 hours
• do not use more than 6 times in 24 hours

Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Childrens Sudafed PE Other information

• each 5 mL (1 tsp) 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
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

NDC 50580-784-04

NON-DROWSY
children's
SUDAFED PE ^®
NASAL
DECONGESTANT

Phenylephrine HCl oral solution
Nasal decongestant

• ✓ Sinus Pressure
  & Stuffy Nose
  Phenylephrine HCl

Due to Colds
& Allergies

Raspberry
Flavor Liquid
Alcohol &
Sugar Free

4 fl oz (118 ml)
2.5 mg per 5 ml