Label: NIGHT TIME COUGH- 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 4, 2019

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  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Cough suppressant

    Antihistamine

  • Uses

    • temporarily relieves cold symptoms
    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing
  • Warnings

    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

    • glaucoma
    • 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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    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.

    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) right away.

  • Directions

    • do not take more than 4 doses in any 24-hour period
    • take only as directed
    • measure only with dosing cup provided. Do not use any other dosing device
    • mL = milliliter
    • adults and children 12 years and over: 30 mL every 6 hours
    • children under 12 years of age: do not use
  • Other information

    • each 30 mL contains; sodium 29 mg
    • store between 20-25ºC (68-77º). Do not refrigerate.
  • 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

  • Questions or comments?

     Call 1-877-753-3935  Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to active ingredients in Vicks'® Nyquil® Cough*

    NightTime Cough

    all night cough relief

    dextromethorphan HBr

    doxylamine succinate

    relieves

    • cough
    • runny nose & sneezing

    for ages12 and over

    alcohol 10%

    cherry flavor

    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.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590


  • Product Label

    Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

    READYinCASE NightTime Cough

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0499
    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
    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    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0499-2355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2017
    2NDC:49580-0499-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/31/2017
    Labeler - P & L Development, LLC (101896231)
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