CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD

Dosage form: liquid
Ingredients: chlorpheniramine maleate 1.0mg in 1mL, dextromethorphan hydrobromide 7.5mg in 5mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-2238

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Children’s Dimetapp Long-Acting Cough plus Cold
(chlorpheniramine maleate and dextromethorphan HBr)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOON)

Chlorpheniramine maleate, USP 1.0 mg

Dextromethorphan HBr, USP 7.5 mg

PURPOSES

Antihistamine

Cough suppressant

USES
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • 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.

Ask a doctor before use if you have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a 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

Ask a doctor or pharmacist before use if you are

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

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 4 doses in any 24-hour period
agedose
12 years and over4 tsp every 6 hours
6 to under 12 years2 tsp every 6 hours
under 6 yearsdo 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 DOSING INFORMATION

Children’s Dimetapp Long Acting Cough Plus Cold

CHLORPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Up to 8 hours of cough control

Relieves Nasal Symptoms

  • Runny Nose
  • Sneezing

Plus Other Symptoms

  • Itchy, Watery Eyes
  • Cough

For Ages 6 Yrs. & Over

4 FL OZ (118mL) 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 Consumer Healthcare, Madison, NJ 07940 U.S.A. ©2008 Wyeth

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

CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD 
chlorpheniramine maleate, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2238
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate1.0 mg  in 1 mL
dextromethorphan hydrobromide (dextromethorphan ) dextromethorphan hydrobromide7.5 mg  in 5 mL
Product Characteristics
ColorPURPLE (purple liquid) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-2238-131 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/04/2005
Labeler - Richmond Division of Wyeth (829390827)

Revised: 06/2009
 
Richmond Division of Wyeth

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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