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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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)