COUGH RELIEF NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • COUGH RELIEF NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

COUGH RELIEF NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-237-12
Set ID 2780ecd5-eeaf-483e-8e85-0bb64b806ebc
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (Chain Drug Marketing Association)
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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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 worse or 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) immediatly.

  • Directions

    • take only as recommended
    • do not exceed 4 doses per 24 hours
    • use dosage cup provided
    • mL = milliliter
    agedose 
     adults & children 12 years and over 30 mL every 6 hours
     children 4 to 11 years do not use unless directed by a doctor
     children under 4 years do not use

    • When using DayTime and Nighttime products,carefully read each label to ensure 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

  • Questions or comments?

     Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredients in VICKS® NYQUIL® Cough

    Nighttime Cough

    Cough Relief 

    Dextromethorphan HBr | Doxylamine Succinate

    For Relief of:

    cough | Runny Nose & Sneezing

    For Ages 12 & Over

    Alcohol 10 %

    FL OZ (mL)

    CHERRY FLAVOR

    *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.

    Failure to follow these warnings could result in serious consequences.

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Product Label

    Dextromethorphan HBr 30 mg, Doxylamine succinate 12.5 mg

    Quality Choice NightTime Cough Relief

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF  NIGHTTIME
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-237
    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:63868-237-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/201612/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/31/201612/30/2022
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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