Label: DELSYM- dextromethorphan suspension, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-6003-0 - Packager: Physicians Total Care, Inc.
- 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 August 30, 2012
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
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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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DELSYM
dextromethorphan suspension, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6003(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) ethylcelluloses (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 Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6003-0 1 in 1 CARTON 1 89 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018658 03/13/2009 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-6003)