Label: 12 HOUR COUGH RELIEF- dextromethorphan hydrobromide suspension
- NDC Code(s): 55312-384-21
- Packager: Western Family Foods Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 8, 2012
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- Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USPClose
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the impulse to cough to help you get to sleep
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)
Stop use and ask a doctor if
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.Close
- 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
- 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
- each 5 mL contains: sodium 5 mg
- store at 20° to 25°C (68° to 77°F)
- dosing cup provided
- Inactive Ingredients
D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gumClose
- Questions or comments?
- Package/Label Principal Display Panel
12 HOUR COUGH RELIEF
DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION
Dosing Cup Included
COMPARE TO ACTIVE INGREDIENT IN DELSYM®
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactionsClose
- INGREDIENTS AND APPEARANCE
12 HOUR COUGH RELIEF
dextromethorphan polistirex suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-384 Route of Administration ORAL DEA Schedule 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) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONES (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:55312-384-21 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 ANDA ANDA091135 09/14/2012 Labeler - Western Family Foods Inc (192166072)