Label: DELSYM- dextromethorphan suspension, extended release
- NDC Code(s): 17856-0172-1, 17856-0172-2, 17856-0172-3, 17856-0172-4
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 63824-171
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 19, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
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)
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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 over 10 mL every 12 hours,
not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hourschildren under 4 years of age do not use - Other information
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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?
- SPL UNCLASSIFIED SECTION
- NDC 17856-0172-01Delsym® Dextromethorphan PolistirexExtended-Release Suspension (Cough Suppressant) COUGH 12HOURCOUGH RELIEF® GrapeFlavored Liquid 10mL CUP 72 PER CASE Day or NightSULFITE FREEALCOHOL FREE
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INGREDIENTS AND APPEARANCE
DELSYM
dextromethorphan suspension, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0172(NDC:63824-171) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0172-4 1 in 1 CUP, UNIT-DOSE 04/19/2024 1 NDC:17856-0172-1 72 in 1 BOX, UNIT-DOSE 1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:17856-0172-3 1 in 1 CUP, UNIT-DOSE 04/19/2024 2 NDC:17856-0172-2 72 in 1 BOX, UNIT-DOSE 2 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018658 12/17/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 repack(17856-0172)