DELSYM - dextromethorphan suspension, extended release 
Physicians Total Care, 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

  • 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

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     You may also report side effects to this phone number.

Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224 ©RB 2011

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton

NDC 54868-6003-0

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

DAY
OR
NIGHT

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

89 mL (3 fl oz)

Alcohol-free

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
DELSYM 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6003(NDC:63824-175)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Polistirex (UNII: 5H9W9GTW27)  
citric acid monohydrate (UNII: 2968PHW8QP)  
edetate disodium (UNII: 7FLD91C86K)  
ethylcelluloses (UNII: 7Z8S9VYZ4B)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
high fructose corn syrup (UNII: XY6UN3QB6S)  
methylparaben (UNII: A2I8C7HI9T)  
polyethylene glycol 3350 (UNII: G2M7P15E5P)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sucrose (UNII: C151H8M554)  
tragacanth (UNII: 2944357O2O)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6003-01 in 1 CARTON
189 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865803/13/2009
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-6003)

Revised: 8/2012
Document Id: d5eac7eb-f3db-4562-a97b-f4f2117d361b
Set id: 671b249d-60f8-450d-8888-269552339b2f
Version: 1
Effective Time: 20120830
 
Physicians Total Care, Inc.