CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD description, usages, side effects, indications, overdosage, supplying and lots more!

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CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD

Richmond Division of Wyeth

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
age dose
12 years and over 4 tsp every 6 hours
6 to under 12 years 2 tsp every 6 hours
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 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

CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD

chlorpheniramine maleate, dextromethorphan HBr LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0031-2238
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1.0 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 7.5 mg

Product Characteristics

Color
PURPLE (purple liquid)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:0031-2238-13 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-03-04


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Be sure to consult your doctor before taking any medication!
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