Label: NIGHT TIME COUGH- dextromethorphan hydrobromide, doxylamine succinate liquid
Contains inactivated NDC Code(s)
NDC Code(s): 49580-0499-2, 49580-0499-4
- Packager: P & L Development, LLC
- 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 December 4, 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
- a breathing problem or chronic cough that lasts or as occurs with smoking, chronic bronchitis,or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to enlarged prostate gland
When using this product
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- 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,come 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 active ingredients in Vicks'® Nyquil® Cough*
all night cough relief
- runny nose & sneezing
for ages12 and over
FL OZ (mL)
*This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
200 Hicks Street
Westbury, NY 11590
- Product Label
INGREDIENTS AND APPEARANCE
NIGHT TIME COUGH
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0499 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:49580-0499-2 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2017 2 NDC:49580-0499-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/31/2017 Labeler - P & L Development, LLC (101896231)