Childrens SUDAFED PE Cold and Cough

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Childrens SUDAFED PE Cold and Cough

FULL PRESCRIBING INFORMATION: CONTENTS*

• Use
• Warnings
  • Do not use
  • Ask a doctor before use if the child has
  • Stop use and ask a doctor if
• Directions
• Childrens SUDAFED PE Cold and Cough Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Use

• temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
  • cough
  • nasal congestion

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)

Directions

• find right dose on chart below
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• if needed, repeat dose every 4 hours
• do not give more than 6 times in 24 hours.

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

Childrens SUDAFED PE Cold and Cough Other information

• each teaspoon contains: sodium 15 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 blue #1, 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 50580-785-04

NON-DROWSY
children's
SUDAFED PE ^®
COLD &
COUGH

• ✔ Sinus Pressure
  & Stuffy Nose
  Phenylephrine HCl
• ✔ Cough
  Dextromethorphan
  HBr

Grape
Flavor Liquid
Alcohol & Sugar Free

4 fl oz (118 mL)