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

Children's Dimetapp Cold & Allergy(brompheniramine maleate and phenylephrine HCl)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 10 ML)

Brompheniramine maleate, USP 2 mg

Phenylephrine HCl , USP 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):
    • 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
  • measure only with dosage cup provided
  • keep dosage cup with product
  • ml = milliliter
age dose
adults and children 12 years and over 20 ml every 4 hours
children 6 to under 12 years 10 ml every 4 hours
children under 6 years do not use

OTHER INFORMATION

  • each 10 ml contains: sodium 6 mg
  • store at 20-25°C (68-77°F)

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

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Children's
Dimetapp®

Cold
& Allergy

BROMPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves Nasal Symptoms

✓ Stuffy Nose
✓ Runny Nose
✓ Sneezing

Plus Other Symptoms

✓ Itchy, Watery Eyes

alcohol-free • grape flavor

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

4 FL OZ (118 ml)

CHILDRENS DIMETAPP COLD AND ALLERGY

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Children's
Dimetapp®

BROMPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)

Cold
& Allergy

Relieves Nasal Symptoms

✓ Stuffy Nose
✓ Runny Nose
✓ Sneezing

Plus Other Symptoms

✓ Itchy, Watery Eyes

For Ages
6 Yrs.
& Over

4 FL OZ (118 ml) alcohol-free • grape flavor

CHILDRENS DIMETAPP COLD AND ALLERGY

CHILDRENS DIMETAPP COLD AND ALLERGY

brompheniramine maleate, phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0031-2235
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

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
propylene glycol
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
PURPLE (purple liquid)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 237 in 1 BOTTLE
3 NDC:0031-2235-19 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-02-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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