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Childrens Delsym Cough Plus Chest Congestion DM

Medically reviewed on June 8, 2017.

Dosage form: solution
Ingredients: Dextromethorphan Hydrobromide 5mg in 5mL, Guaifenesin 100mg in 5mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-214

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 Delsym®
Cough Plus® Chest Congestion DM

Drug Facts

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
Age (year)Dose (mL)
children 6 to under 12 years of age5 mL - 10 mL every 4 hours
children 4 to under 6 years of age2.5 mL - 5 mL every 4 hours
children under 4 years of agedo not use

Other information
  • each 5 mL contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum


may contain this ingredient

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

031113
8079219

Children's
Delsym®

NDC 63824-214-66

COUGH + ™
CHEST
CONGESTION

DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Age 4+

Cough
Chest Congestion
Thins & Loosens
Mucus

6 fl oz (180 mL)

Cherry Flavor

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-214-64
Ages 4 Years +

Children's
Delsym®

COUGH + ®
Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Relieves Cough
Relieves Chest
Congestion
Thins &
Loosens
Mucus

Cherry Flavor

4 fl oz (118 mL)

CHILDRENS DELSYM   COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-214
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
edetate disodium 
FD&C Red No. 40 
glycerin 
propylene glycol 
propyl gallate 
water 
sodium benzoate 
sorbitol 
sucralose 
trisodium citrate dihydrate 
xanthan gum 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-214-66180 mL in 1 BOTTLE
2NDC:63824-214-641 BOTTLE in 1 CARTON
2118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2013
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

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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