CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION

Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.

Children’s Dimetapp Nighttime Cold & Congestion(diphenhydramine HCl and phenylephrine HCl)

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENTS (IN EACH 5 ML TSP)
• PURPOSES
• USES
• WARNINGS
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS OR COMMENTS?
• PRODUCT PACKAGING

FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Diphenhydramine HCl, USP 6.25 mg

Phenylephrine HCl, USP 2.5 mg

PURPOSES

Antihistamine/Cough suppressant

Nasal decongestant

USES

• temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies:
  • nasal congestion
  • cough
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS

Do not use

• to sedate a child or to make a child sleepy
• If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• do not take more than 6 doses in any 24-hour period
• do not exceed recommended dosage

OTHER INFORMATION

• each teaspoon contains: sodium 4 mg
• store at 20 -25°C (68 -77°F)
• dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

SEE NEW WARNING INFORMATION

Children’s Dimetapp Nighttime Cold & Congestion

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves Nasal Symptoms

• Stuffy Nose
• Runny Nose
• Sneezing

Plus Other Symptoms

• Itchy, Watery Eyes
• Cough

For Ages 6 Yrs. & Over

4 FL OZ (118 mL) grape flavor

For most recent product information, visit www.dimetapp.com

We pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family.

Dosage Cup Provided

Wyeth

Wyeth Consumer Healthcare

Madison, NJ 07940 USA

©2009 Wyeth

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.