DELSYM (DEXTROMETHORPHAN)- dextromethorphan suspension, extended release 
Atlantic Biologicals Corps

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Delsym (Dextromethorphan) Suspension Extended-Release ®

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

Warnings

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. Do not use

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)

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. Stop use and ask a doctor if

ask a health professional before use. If pregnant or breast-feeding,

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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, 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

DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE

Label Image
DELSYM (DEXTROMETHORPHAN) 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0276(NDC:63824-177)
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:17856-0276-110 mL in 1 CUP; Type 0: Not a Combination Product05/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865808/19/2011
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-0276) , REPACK(17856-0276)

Revised: 5/2016
Document Id: bdd04e98-34da-44e9-b6e6-5e7eb3d23294
Set id: 56f5f9d1-54a6-48a5-8033-efc29e632479
Version: 2
Effective Time: 20160504
 
Atlantic Biologicals Corps