ROBITUSSIN LINGERING COLD LONG-ACTING COUGH

Dosage form: liquid
Ingredients: dextromethorphan hydrobromide 15mg in 5mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8740

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.

Robitussin Lingering Cold Long-Acting Cough
(dextromethorphan HBr)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH 5 ML TSP)

Dextromethorphan HBr, USP 15 mg

PURPOSE

Cough suppressant

USE

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

WARNINGS

Do not use

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
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

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
agedose
children under 12 yearsdo not use
adults and children 12 years and over2 teaspoons every 6 to 8 hours

OTHER INFORMATION
  • store at 20-25°C (68-77°F)
  • dosage cup provided

INACTIVE INGREDIENTS

alcohol, anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, purified water, saccharin sodium, sodium benzoate

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM-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.

ADULT

Robitussin LINGERING COLD Long-Acting Cough

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

  • Cough for up to 8 Hours

Alcohol 1.4%

Non-Drowsy

For Ages 12 & Over

4 FL OZ (118 ml)

Find the right product for you with the Robitussin Relief Finder on Robitussin.com

  • at home
  • on your mobile phone

Use dosage cup included

Pfizer, Madison, NJ 07940 USA

© 2011 Pfizer Inc.

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

Droplet is not representative of actual product color.

Should be 18 or older to purchase

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.

Stop use and ask a doctor if cough lasts more than 7 days.

ROBITUSSIN LINGERING COLD LONG-ACTING COUGH 
dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8740
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
alcohol 
anhydrous citric acid 
FD&C red no. 40 
glycerin 
high fructose corn syrup 
menthol 
saccharin sodium 
sodium benzoate 
water 
Product Characteristics
ColorRED (dark red-colored syrup) Score    
ShapeSize
FlavorCHERRY (mentholated cherry-vanilla flavor and odor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8740-121 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2011
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK

Revised: 12/2011
 
Richmond Division of Wyeth

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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