Childrens Robitussin Cough Long-Acting

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 7.5mg in 5mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8694

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.

Children's Robitussin® Cough Long-Acting

Drug Facts

Active ingredient (in each 5 ml tsp)

Dextromethorphan HBr, USP 7.5 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

  • cough that occurs with too much phlegm (mucus)
  • 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
agedose
children under 6 yearsdo not use
children 6 to
under 12 years
2 teaspoons
every 6 to 8 hours
adults and children
12 years and older
4 teaspoons
every 6 to 8 hours

Other information
  • each teaspoon contains: sodium 5 mg
  • store at 20-25°C (68-77°F)
  • dosage cup provided

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by:
Pfizer, Madison, NJ 07940 USA

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Children's
Robitussin®
Cough

DEXTROMETHORPHAN HBr (Cough Suppressant)

LONG-ACTING

RELIEVES:

Cough: Up to 8 Hours

See NEW Dosing
Information

FRUIT PUNCH Flavor

For Children Ages 6 & Over
Alcohol-Free

4 FL OZ (118 ml)

CHILDRENS ROBITUSSIN COUGH LONG-ACTING 
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8694
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL, (R)- 
WATER 
SACCHARIN SODIUM DIHYDRATE 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
Product Characteristics
ColorRED (bright red) Score    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8694-121 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2004
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245ANALYSIS(0031-8694), LABEL(0031-8694), MANUFACTURE(0031-8694), PACK(0031-8694), RELABEL(0031-8694), REPACK(0031-8694)

Revised: 09/2012
 
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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