Label: DEXTROMETHORPHAN POLISTIREX suspension, extended release
- NDC Code(s): 58602-611-05, 58602-611-06
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 4, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- 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
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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 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 or comments?
- PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label
- PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label
-
INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN POLISTIREX
dextromethorphan polistirex suspension, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-611 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 AQUEOUS DISPERSION TYPE B (UNII: HZJ2V81RYU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GRAPE (UNII: 6X543N684K) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) TRAGACANTH (UNII: 2944357O2O) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PURPLE (Purple to dark purple) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-611-05 1 in 1 CARTON 04/15/2026 1 89 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:58602-611-06 1 in 1 CARTON 04/15/2026 2 148 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218417 04/15/2026 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650918514 ANALYSIS(58602-611) , MANUFACTURE(58602-611)
