Label: COUGH DM- dextromethorphan polistirex suspension
- NDC Code(s): 0904-6312-56
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
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)
- 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 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 or comments?
-
Package/Label Principal Display Panel
Compare to the active ingredient of Delsym®
Cough DM
Dextromethorphan Polistirex Extended-Release Oral Suspension
Cough Suppressant
12 Hour Cough Relief
Day or Night
Orange-Flavored Liquid
Alcohol-Free
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions
3 FL OZ (89 mL)
Dosing Cup Included
-
INGREDIENTS AND APPEARANCE
COUGH DM
dextromethorphan polistirex suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6312 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength POLISTIREX (UNII: 5H9W9GTW27) D&C RED NO. 30 (UNII: 2S42T2808B) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ACETATE (UNII: 32K497ZK2U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z) SUCROSE (UNII: C151H8M554) TARTARIC ACID (UNII: W4888I119H) TRAGACANTH (UNII: 2944357O2O) TRIACETIN (UNII: XHX3C3X673) 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:0904-6312-56 1 in 1 CARTON 09/06/2012 1 89 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091135 09/06/2012 Labeler - Major Pharmaceuticals (191427277)