Label: NIGHT TIME COUGH CHERRY- 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 7, 2021

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  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purposes

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves cold symptoms

    • cough
    • runny nose and sneezing
  • Warnings

    Do not use

    • to make a child sleepy
    • 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 sodium-restricted diet
    • asthma
    • emphysema
    • glaucoma
    • chronic bronchitis
    • excessive phlegm (mucus)
    • breathing problems
    • persistent or chronic cough
    • cough associated with smoking
    • 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
    • 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

    • fever gets worseor lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain or cough gets worse or lasts more than 7 days
    • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • take only as recommended
    • do not exceed 4 doses per 24 hours
    • use dosing cup provided
    • mL= milliliter
     agedose
    adults & children 12 years and over30 mL every 6 hours
    children 4 to 11 yearsdo not use unless directed by a doctor
    children under 4 yearsdo not use
    • When using other Day Time or Night Time products, carefully read each label to insure correct dosing
  • Other information

    • each 30 mL contains; sodium 36 mg
    • store at room temperature
  • Inactive ingredients

    alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Principal Display Panel

    *Compare to active ingredients in Vicks® NyQuil® Cough

    Cherry

    Night Time Cough

    Cold & Cough Relief

    Dextromethorphan hBr- Cough Suppressant

    Doxylamine Succinate- Antihistamine

    • For Ages 12 & Over
    • Alcohol 10%

    FL OZ (mL)

    *This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® NyQuil® Cough.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

    Disributed by:

    Marc Glassman, Inc.

    West 130th Street

    Cleveland, OH 44130

  • Product Label

    Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

    Marc's NightTime Cough Cherry Liquid

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME COUGH  CHERRY
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-345
    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
    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)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-345-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/201412/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/31/201412/29/2023
    Labeler - Marc Glassman, Inc. (094487477)
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