DELSYM (DEXTROMETHORPHAN)- dextromethorphan suspension, extended release 
RB Health (US) LLC

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Delsym ®(Dextromethorphan) Suspension
Extended-Release

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

Stop use and ask a doctor ifcough lasts more than 7 days, 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, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Distributed by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 63824-177-65
Ages 4+

Children's
Delsym ®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

Day
or
Night

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

148 mL (5 fl oz)
For Children & Adults

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton
DELSYM (DEXTROMETHORPHAN) 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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)  
ETHYLCELLULOSE, UNSPECIFIED (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:63824-177-631 in 1 CARTON08/19/2011
189 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:63824-177-651 in 1 CARTON07/01/201710/03/2024
2148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865808/19/2011
Labeler - RB Health (US) LLC (081049410)

Revised: 4/2024
Document Id: 159c6a88-9acb-cd0e-e063-6394a90ac5f1
Set id: ce4b477c-430e-40a3-b247-b3914ef17793
Version: 7
Effective Time: 20240408
 
RB Health (US) LLC