DELSYM- dextromethorphan suspension, extended release 
ATLANTIC BIOLOGICALS CORP.

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Delsym
12 Hour Cough Relief
Grape

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 anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, 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:


ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE

MIAMI, FL 33179

NDC 17856-0172-01Delsym® Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant) COUGH 12
HOUR
COUGH RELIEF® Grape
Flavored Liquid 10mL CUP 72 PER CASE Day or Night
SULFITE FREE
ALCOHOL FREE

image description

image description

DELSYM 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0172(NDC:63824-171)
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)  
anhydrous citric acid (UNII: XF417D3PSL)  
D&C Red NO. 33 (UNII: 9DBA0SBB0L)  
edetate disodium (UNII: 7FLD91C86K)  
ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
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
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0172-41 in 1 CUP, UNIT-DOSE04/19/2024
1NDC:17856-0172-172 in 1 BOX, UNIT-DOSE
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-0172-31 in 1 CUP, UNIT-DOSE04/19/2024
2NDC:17856-0172-272 in 1 BOX, UNIT-DOSE
25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865812/17/2018
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707repack(17856-0172)

Revised: 4/2024
Document Id: cc5c2a0f-bedb-4702-829f-0bb7b3ea1abf
Set id: 00f8f5b4-f5a8-4dcf-8133-15964ad4801e
Version: 5
Effective Time: 20240419
 
ATLANTIC BIOLOGICALS CORP.