CHILDRENS DIMETAPP COLD AND ALLERGY description, usages, side effects, indications, overdosage, supplying and lots more!

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CHILDRENS DIMETAPP COLD AND ALLERGY

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

CHILDREN’S DIMETAPP COLD & ALLERGY CHEWABLE TABLETS(brompheniramine maleate and phenylephrine HCl)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

PURPOSES

Antihistamine

Nasal decongestant

USES

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • 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
  • a breathing problem such as emphysema, asthma or chronic bronchitis

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
  • drowsiness may occur
  • 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

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 tablets every 4 hours
children 6 to under 12 years 2 tablets every 4 hours
children under 6 years do not use

OTHER INFORMATION

  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

carmine, carrageenan, croscarmellose sodium, fructose, fumaric acid, glycine, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavor, polyethylene oxide, silicon dioxide, sorbitol, sucralose, tribasic calcium phosphate

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 & Allergy

BROMPHENIRAMINE MALEATE (Antihistamine)

PHENYLEPHRINE HCI (Nasal Decongestant)

Relieves Nasal Symptoms

  • Stuffy Nose
  • Runny Nose
  • Sneezing

Plus Other Symptoms

  • Itchy, Watery Eyes

For Ages 6 Yrs. & Over

20 chewable tablets

grape flavor

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

Wyeth Consumer Healthcare Madison, NJ 07940 USA ©2009 Wyeth

Made in Canada

TABLETS INDIVIDUALLY BLISTER SEALED. IF SEAL IS BROKEN, DO NOT USE.

CHILDRENS DIMETAPP COLD AND ALLERGY

CHILDRENS DIMETAPP COLD AND ALLERGY

brompheniramine maleate, phenylephrine HCl TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0031-2293
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Product Characteristics

Color Size Imprint Code Shape
PURPLE (mottled, purple-colored chewable tablet) 9 mm DTP ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:0031-2293-21 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-09-27


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Be sure to consult your doctor before taking any medication!
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