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Name:Robitussin Cough And Cold Long Acting
Manufacturer:Richmond Division Of Wyeth
Category:Over-the-counter (OTC) Marketed Drugs


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

ROBITUSSIN COUGH AND COLD LONG ACTING - chlorpheniramine maleate and dextromethorphan hydrobromide liquid 
Richmond Division of Wyeth

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.

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

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 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
  • this adult product is not intended for use in children under 12 years of age
age dose
children under 12 years do not use
adults and children 12 years and over 2 teaspoons every 6 hours

OTHER INFORMATION

  • 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, menthol, 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

Adult

Robitussin Cough & Cold LONG-ACTING

CHLORPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

RELIEVES:

Cough: Up to 8 Hours

Runny Nose

For Ages 12 & 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.

Robitussin Cough & Cold Long-Acting Packaging

ROBITUSSIN COUGH AND COLD LONG ACTING 
chlorpheniramine maleate, dextromethorphan hbr liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8667
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chlorpheniramine maleate (chlorpheniramine ) chlorpheniramine maleate 2 mg  in 5 mL
dextromethorphan hydrobromide (dextromethorphan ) dextromethorphan hydrobromide 15 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0031-8667-13 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (0031-8667-13)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/09/2007

Labeler - Richmond Division of Wyeth (829390827)

Revised: 06/2009 Richmond Division of Wyeth



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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