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Childrens Robitussin Nighttime Cough Long-Acting DM

Medically reviewed on July 16, 2018

Dosage form: solution
Ingredients: CHLORPHENIRAMINE MALEATE 2mg in 10mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 10mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8692

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® Nighttime Cough Long-Acting DM

Drug Facts

Active ingredients (in each 10 ml)Purposes
Chlorpheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 15 mgCough 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

  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • do not take more than 4 doses in any 24-hour period
agedose
children under 6 yearsdo not use
children 6 to under 12 years10 ml every 6 hours
adults and children 12 years and older20 ml every 6 hours

Other information

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

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

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

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Children's

Robitussin®

AGES 6 & OVER

Nighttime
Cough

Long-Acting

DM

CHLORPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves Cough up to 8 Hours
& Runny Nose

Alcohol-Free

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Children's

Robitussin®

AGES 6 & OVER

Nighttime
Cough

Long-Acting

DM

CHLORPHENIRAMINE MALEATE
(Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

Cough Up to 8 Hours
Runny Nose

Alcohol-Free

fruit
punch

flavor

4 FL OZ
(118 ml)

CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM 
chlorpheniramine maleate, dextromethorphan hydrobromide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8692
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
LACTIC ACID 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorRED (red) Score    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8692-131 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2014
Labeler - Richmond Division of Wyeth (829390835)

 
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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