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

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep

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

  • shake bottle well before use
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
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

  • each 5 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided

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

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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:17856-0172-172 in 1 BOX, UNIT-DOSE12/17/2018
110 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) , relabel(17856-0172)

Revised: 8/2020
Document Id: adc0c13b-6e52-44e7-9684-113e7ddb0c83
Set id: 00f8f5b4-f5a8-4dcf-8133-15964ad4801e
Version: 2
Effective Time: 20200821
 
ATLANTIC BIOLOGICALS CORP.