Label: NIGHTTIME COUGH ALL NIGHT COUGH RELIEF- dextromethorphan hydrobromide, doxylamine succinate liquid
- NDC Code(s): 49580-0345-1, 49580-0345-2, 49580-0345-4, 49580-0345-6
- 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.
Updated May 24, 2023
If you are a consumer or patient please visit this version.
- 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 thats lasts or as occurs with smoking, asthma, 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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
Principal Display Panel
Compare to active ingredients in Vicks® NyQuil® Cough*
all night cough relief
- runny nose
for ages 12 and over
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & 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.
11865 S. Alameda St
Lynwood, CA 90262
- Product Label
INGREDIENTS AND APPEARANCE
NIGHTTIME COUGH ALL NIGHT COUGH RELIEF
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0345 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0345-1 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2014 12/31/2024 2 NDC:49580-0345-6 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2014 12/31/2024 3 NDC:49580-0345-2 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2014 12/31/2024 4 NDC:49580-0345-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2014 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2014 12/31/2024 Labeler - P & L Development, LLC (101896231)