Label: MUCINEX CHILDRENS MIGHTY CHEWS COUGH NIGHTTIME- dextromethorphan hbr and doxylamine succinate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 5, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg

  • PURPOSE

    Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant
    Doxylamine succinate 6.25 mg.................................................Antihistamine

  • Uses

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

  • WARNINGS

    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 ■ glaucoma
    ■ trouble urinating due to an enlarged prostate gland
    ■ a breathing problem such as emphysema or chronic bronchitis
    ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    ■ cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are
    ■ taking sedatives or tranquilizers

    When using this product
    ■ do not exceed recommended dosage
    ■ excitability may occur, especially in children
    ■ marked drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness
    ■ avoid alcoholic drinks
    ■ use caution when driving a motor vehicle or operating machinery

    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.

  • KEEP OUT OF REACH OF CHILDREN

    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

  • DOSAGE & ADMINISTRATION

    Directions
    ■ take every 4 hours, or as directed by a doctor
    ■ chew thoroughly before swallowing

    adults and children 12 years
    of age and over
    2 chewable tablets every 4 hours, not to exceed
    12 chewable tablets in any 24-hour period
    children 6 to under 12 years
    of age
    1 chewable tablet every 4 hours, not to exceed
    6 chewable tablets in any 24-hour period
    children under 6 years of agedo not use

  • OTHER SAFETY INFORMATION

    Other information
    ■ each chewable tablet contains: potassium 5 mg and sodium 15 mg
    ■ Store in a cool dry place at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    anhydrous citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40,
    flavors, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate,
    purified water, sodium chloride, trisodium citrate (anhydrous), sodium
    polymetaphosphate, sucralose, sucrose

  • QUESTIONS

    Questions? 1-866-MUCINEX (1-866-682-4639)

  • PRINCIPAL DISPLAY PANEL

    NDC 72854-082-16

    Children's
    Mucinex®

    Cough Suppressant

    Antihistamine

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 m

    Age 6+

    Mixed Berry Flavor

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS MIGHTY CHEWS COUGH NIGHTTIME 
    dextromethorphan hbr and doxylamine succinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PECTIN (UNII: 89NA02M4RX)  
    POTASSIUM SODIUM TARTRATE (UNII: QH257BPV3J)  
    WATER (UNII: 059QF0KO0R)  
    MALIC ACID (UNII: 817L1N4CKP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize23mm
    FlavorBERRY (Mixed Berry) Imprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-082-1616 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)06/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/03/2024
    Labeler - RB Health (US) LLC (081049410)