CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING description, usages, side effects, indications, overdosage, supplying and lots more!

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CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING

Richmond Division of Wyeth

Children’s Robitussin Cough & Cold Long-Acting(chlorpheniramine maleate and dextromethorphan HBr)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Chlorpheniramine maleate, USP 1 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
under 6 years do not use
6 to under 12 years 2 teaspoons every 6 hours
12 years and older 4 teaspoons every 6 hours

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 & natural flavors, FD&C red no. 40, glycerin, lactic acid, 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 Robitussin Cough & Cold LONG-ACTING

CHLORPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

RELIEVES:

Cough: Up to 8 Hours

Runny Nose

FRUIT PUNCH Flavor

For Children Ages 6 & Over

Alcohol-Free

4 FL OZ (118 mL)

Robitussin Knows

Choosing the right product is important. Robitussin has different products for adults and for children.

GREEN Boxes

Ages 12 & Over

RED Boxes

Ages Under 12

Use as directed

DOSAGE CUP INCLUDED

Wyeth Consumer Healthcare Madison, NJ 07940 U.S.A. © 2009 Wyeth

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

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

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

CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING

CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING

chlorpheniramine maleate, dextrometrorphan HBr LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0031-8693
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 7.5 mg

Product Characteristics

Color
RED (red liquid)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:0031-8693-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2004-01-01


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Be sure to consult your doctor before taking any medication!
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