Label: DELSYM- dextromethorphan suspension, extended release
- NDC Code(s): 50090-0224-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 63824-175
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 25, 2023
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- 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 such 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
adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- Dextromethorphan
-
INGREDIENTS AND APPEARANCE
DELSYM
dextromethorphan suspension, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0224(NDC:63824-175) 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) 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 ORANGE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0224-0 1 in 1 CARTON 11/28/2014 1 89 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018658 05/04/2010 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0224)