Label: NIGHTTIME COUGH RELIEF- dextromethorphan hbr, doxylamine succinate solution
- NDC Code(s): 11822-0668-1, 11822-0668-2
- Packager: Rite Aid Corporation
- 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 April 14, 2016
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- Active ingredients (in each 30 mL)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mgClose
temporarily relieves cold symptoms:
- cough due to minor throat and bronchial irritation
- runny nose and sneezing
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)
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
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
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
30 mL every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- Other information
- each 30 mL contains: sodium 32 mg
- store at 20-25 °C (68-77 °F)
- Inactive ingredients
alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, 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 ingredients of Vicks® NyQuil® Cough
all night cough relief
8 FL OZ (237 mL)Close
- INGREDIENTS AND APPEARANCE
NIGHTTIME COUGH RELIEF
dextromethorphan hbr, doxylamine succinate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0668 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 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED (Dark Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0668-1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11822-0668-2 355 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 08/07/2002 Labeler - Rite Aid Corporation (014578892)