Label: NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution

  • NDC Code(s): 50844-043-36
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 21, 2023

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 30 mg
    Doxylamine Succinate 12.5 mg

  • Purpose

    Cough suppressant
    Antihistamine

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • itching of the nose or throat 
      • sneezing
      • itchy, watery eyes
      • runny nose
    • controls the impulse to cough to help you sleep
  • 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

    • a cough that occurs with too much phlegm (mucus)
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    cough persists more than 7 days, tends to recur, or is accompanied by a 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 right away.

  • Directions

    • do not take more than directed
    • do not take more than 4 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours
    • children under 12 years: do not use
  • Other information

    • each 20 mL contains: sodium 14 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    NDC 50844-043-36

    Quality 
    Plus 

    Compare to the active ingredients
    in Robitussin® MAXIMUM STRENGTH
    Nighttime Cough DM*

    MAXIMUM STRENGTH

    NIGHTTIME
    COUGH DM

    DEXTROMETHORPHAN HBr
    Cough suppressant
    DOXYLAMINE SUCCINATE
    Antihistamine

    • Controls cough
    • Relieves runny nose & sneezing

    Menthol-Berry
    Flavor

    Ages 12 Years and Over

    4 FL OZ (118 mL)

    Dosage cup
    included

    *This product is not manufactured or
    distributed by PF Consumer Healthcare 1 LLC,
    owner of the registered trademark Robitussin®
    MAXIMUM STRENGTH Nighttime Cough DM.
    50844        REV0123A04336

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    Quality Plus 44-043

    Quality Plus 44-043

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH DM 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorred (maroon) Score    
    ShapeSize
    FlavorBERRY, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-043-361 in 1 CARTON07/16/2021
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/16/2021
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(50844-043) , pack(50844-043)
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