Label: COUGH- dextromethorphan hbr solution
- NDC Code(s): 42507-500-40
- Packager: HyVee Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 31, 2016
If you are a consumer or patient please visit this version.
- Active ingredient (in each 15 mL)
Dextromethorphan HBr 15 mgClose
temporarily relieves cough due to minor throat and bronchial irritation associated with a coldClose
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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).
- take only as directed
- use dose cup
- do not exceed 4 doses per 24 hours
adults and children 12 years and over
30 mL every 6-8 hours
children 6 to under 12 years
15 mL every 6-8 hours
children 4 to under 6 years
ask a doctor
children under 4 years
do not use
- Other information
- each 15 mL contains: sodium 13 mg
- store at 20-25 °C (68-77 °F)
- does not meet USP requirements for light resistant packaging
- Inactive ingredients
anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrateClose
- Questions or comments?
- Principal Display Panel
COMPARE TO the Active Ingredient of Vicks® DayQuil® Cough
Dextromethorphan HBr – Cough Suppressant
All Day Cough Relief Up to 8 Hours
Citrus Blend Flavor
12 FL OZ (355 mL)Close
- INGREDIENTS AND APPEARANCE
dextromethorphan hbr solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color ORANGE (light) Score Shape Size Flavor CITRUS (blend) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-500-40 355 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 OTC monograph final part341 02/12/2014 Labeler - HyVee Inc (006925671)