Delsym 12 Hour Cough Relief Orange

DELSYM - dextromethorphan suspension, extended release 
Reckitt Benckiser, Inc.

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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

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

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

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

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

Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009

PRINCIPAL DISPLAY PANEL - 89 mL Carton

NDC 63824-175-63

Delsym®

dextromethorphan polistirex
extended-release suspension

COUGH SUPPRESSANT

SEE NEW DOSING
DIRECTIONS

12
HOUR
Cough Relief

Orange-Flavored Liquid

Alcohol-free

89 mL (3 fl oz)

PRINCIPAL DISPLAY PANEL - 89 mL Carton

DELSYM 
dextromethorphan   suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163824-175-631 BOTTLE In 1 CARTONcontains a BOTTLE
189 mL In 1 BOTTLEThis package is contained within the CARTON (63824-175-63)
263824-175-651 BOTTLE In 1 CARTONcontains a BOTTLE
2148 mL In 1 BOTTLEThis package is contained within the CARTON (63824-175-65)
363824-175-7512 BOTTLE In 1 CARTONcontains a BOTTLE
315 mL In 1 BOTTLEThis package is contained within the CARTON (63824-175-75)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865809/04/2009

Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009Reckitt Benckiser, Inc.