CHILDRENS DIMETAPP COLD AND COUGH - brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.

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Children’s Dimetapp Cold & Cough
(brompheniramine maleate, dextromethorphan HBr, and phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl , USP 2.5 mg

PURPOSES

Antihistamine

Cough suppressant

Nasal decongestant

USES

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• temporarily restores freer breathing through the nose

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.

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 persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not use more than directed
• may cause marked drowsiness
• avoid alcoholic beverages
• 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

age	dose
adults and children 12 years and over	4 tsp every 4 hours
children 6 to under 12 years	2 tsp every 4 hours
children under 6 years	do not use

OTHER INFORMATION

• each teaspoon contains: sodium 3 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, 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 Cold & Cough

BROMPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (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

8 FL OZ (237 mL) alcohol-free 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

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

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.

CHILDRENS DIMETAPP COLD AND COUGH  brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0031-2234 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength brompheniramine maleate (brompheniramine) brompheniramine maleate 1 mg  in 5 mL dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide 5 mg  in 5 mL phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 2.5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PURPLE (purple liquid) Score      Shape Size Flavor GRAPE (grape flavor and odor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0031-2234-13 1 BOTTLE In 1 CARTON contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the CARTON (0031-2234-13) 2 0031-2234-19 1 BOTTLE In 1 CARTON contains a BOTTLE 2 237 mL In 1 BOTTLE This package is contained within the CARTON (0031-2234-19)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/23/2006

Labeler - Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc. (829390827)

Establishment
Name	Address	ID/FEI	Operations
Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.		829390827	MANUFACTURE, ANALYSIS

Revised: 06/2010Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.