Label: NIGHT-TIME COUGH RELIEF- dextromethorphan hydrobromide, doxylamine succinate liquid

  • 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 31, 2020

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  • Drug FactsActive ingredients (in each 30 mL dose cup)

    Dextromethorphan HBr 30 mg

    Doxylamine Succinate 12.5 mg

  • Purpose

    Cough suppressant

    Antihistamine

  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    temporarily relieves cold symptoms:

    • runny nose and sneezing
    • cough
  • Warnings

    DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

    Failure to follow these warnings could result in serious consequences.

  • Do not use

    • if you are now taking a prescription monamine 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.
    • to make a child sleepy
  • Ask a doctor befor use if you have

    • a sodium restricted diet
    • glaucoma
    • 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
  • Ask a doctor or pharmacist before use

    • if you are taking sedatives or tranquilizers
  • When using this product

    • do not use more than directed
    • 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, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • If pregnant or breast feeding,

    ask a health professionalbefore use.

  • Directions

    • Use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours
    • When using Day Time and Night Time products, carefully read each label to ensure
     adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
     children 4 to under 12 years ask a doctor
     children under 4 years do not use

  • Other information

    • each 30 mL dose cup contains: sodium 45 mg
    • store at room temperature
  • Inactive ingredients

    citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

  • Questions ?

    Call weekdays from 9:30 am to 4:30 pm EST.

    1-877-798-5944.

  • DISCOUNT drug martFOOD FAIRCherryNight-TimeCOUGH REFIEF product label

    *COMPARE TO THE INGREDIENTS IN VICKS® NYQUIL® COUGH

    DISCOUNT

    drug mart

    FOOD FAIR

    Cherry

    Night-Time

    COUGH RELIEF

    Dextromethorphan HBr ..... Cough Suppressant

    Doxylamine Succiate ......... Antihistamine

    • Cough
    • Sneezing
    • Runny Nose

    12 FL OZ (354 mL)

    * This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil® Cough

    LR-067

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION ,  NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

    image description

  • INGREDIENTS AND APPEARANCE
    NIGHT-TIME  COUGH RELIEF
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-508-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product10/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/27/2014
    Labeler - Discount Drug Mart (047741335)
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