Label: COUGH RELIEF NIGHTTIME- dextromethorphan hydrobromide, doxylamine succinate liquid
Contains inactivated NDC Code(s)
NDC Code(s): 63868-292-08
- Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- 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.
Drug Label Information
Updated November 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
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 or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- 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 lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
*Compare to the Active Ingredients in VICKS® NYQUIL® Cough
Dextromethorphan HBr | Cough Suppressant
Doxylamine Succinate | Antihistamine
For Relief of:
cough | Runny Nose & Sneezing
For Ages 12 & Over
Alcohol 10 %
FL OZ (mL)
*This product is not manufactured or distributed by The Proctor & Gamble Company.Vicks® NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A., Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
- Product Label
INGREDIENTS AND APPEARANCE
COUGH RELIEF NIGHTTIME
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-292 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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-292-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/31/2018 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)