DELSYM- dextromethorphan suspension, extended release 
Reckitt Benckiser LLC

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Delsym
12 Hour Cough Relief
Orange
for Children & Adults

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, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, 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 ©RB 2011

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 63824-176-65

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH
for
Children
& Adults

DAY
OR
NIGHT

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

148 mL (5 fl oz)

Alcohol-free

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton
DELSYM 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-176
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 DescriptionMarketing Start DateMarketing End Date
1NDC:63824-176-631 in 1 CARTON
189 mL in 1 BOTTLE
2NDC:63824-176-651 in 1 CARTON
2148 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865805/04/2010
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 7/2012
Document Id: e5b9c1d3-3234-4475-9814-47b8b449032d
Set id: d24fb014-9b3e-4bda-be3c-912e788a56a8
Version: 3
Effective Time: 20120711
 
Reckitt Benckiser LLC