Label: COUGH DM CHILDRENS- dextromethorphan polistirex suspension
- NDC Code(s): 41250-899-28
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 18, 2019
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- 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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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 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 Children’s Delsym® active ingredient
CHILDREN’S cough DM
Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant
AGE 4+
12 HOUR Cough Relief
Grape-Flavored Liquid
Day or Night | Alcohol Free
For Children & Adults
Dosing Cup Included
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions
5 FL OZ (148 mL)
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INGREDIENTS AND APPEARANCE
COUGH DM CHILDRENS
dextromethorphan polistirex suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-899 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 D&C RED NO. 30 (UNII: 2S42T2808B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ACETATE (UNII: 32K497ZK2U) POVIDONE (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 PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-899-28 1 in 1 CARTON 03/25/2015 1 148 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 03/25/2015 Labeler - Meijer Distribution Inc (006959555)