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Delsym by Reckitt Benckiser LLC

Medically reviewed on April 9, 2018

Dosage form: suspension, extended release
Ingredients: Dextromethorphan 30mg in 5mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-175

Delsym
12 Hour Cough Relief
Orange

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep

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

Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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
  • shake bottle well before use
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
adults and children 12 years of age and over10 mL every 12 hours,
not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours,
not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours
children under 4 years of agedo not use

Other information
  • each 5 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided

Inactive ingredients

citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

1-888-963-3382
You may also report side effects to this phone number.

Distributed by: Reckitt Benckiser Parsippany, NJ 07054-0224 ©2014 RB

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton

NDC 63824-175-63

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

89 mL (3 fl oz)

Day or Night
Alcohol-free

DELSYM 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan (Dextromethorphan) Dextromethorphan Hydrobromide30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Polistirex 
citric acid monohydrate 
edetate disodium 
ethylcelluloses 
FD&C Yellow No. 6 
high fructose corn syrup 
methylparaben 
polyethylene glycol 3350 
polysorbate 80 
propylene glycol 
propylparaben 
water 
sucrose 
tragacanth 
xanthan gum 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-175-631 BOTTLE in 1 CARTON
189 mL in 1 BOTTLE
2NDC:63824-175-651 BOTTLE in 1 CARTON
2148 mL in 1 BOTTLE
3NDC:63824-175-751 BOTTLE in 1 CARTON
315 mL in 1 BOTTLE
4NDC:63824-175-222 CARTON in 1 CELLO PACK
41 BOTTLE in 1 CARTON
4148 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865805/04/2010
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

See Also

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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