Label: MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 26, 2025

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Acetaminophen 162.5 mg

    Dextromethorphan HBr 5 mg

    Doxylamine succinate 3.125 mg

  • PURPOSE

    Acetaminophen 162.5 mg................................................Pain reliever/fever reducer

    Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant
    Doxylamine succinate 3.125 mg.................................................Antihistamine

  • Uses

    ■ temporarily relieves these common cold and flu symptoms:

    ■ minor aches and pains

    ■ sore throat

    ■ headache
    ■ cough due to minor throat and bronchial irritation as may occur with
    the common cold or inhaled irritants
    ■ runny nose

    ■ sneezing
    ■ temporarily reduces fever
    ■ controls cough to help the user get to sleep

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage
    may occur if:
    ■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is
    the maximum daily amount
    ■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is
    the maximum daily amount
    ■ taken with other drugs containing acetaminophen
    ■ adult has 3 or more alcoholic drinks every day while using this product


    Allergy alert: Acetaminophen may cause severe skin reactions.
    Symptoms may include:
    ■ skin reddening ■ blisters ■ rash


    If a skin reaction occurs, stop use and seek medical help right away.
    Sore throat warning: If sore throat is severe, persists for more than 2 days,
    is accompanied or followed by fever, headache, rash, nausea, or vomiting,
    consult a doctor promptly.


    Do not use
    ■ to make a child sleepy
    ■ with any other drug containing acetaminophen (prescription or
    nonprescription). If you are not sure whether a drug contains
    acetaminophen, ask a doctor or pharmacist.
    ■ if the user is 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
    ■ has liver disease
    ■ has a sodium-restricted diet
    ■ has glaucoma
    ■ has a breathing problem such as emphysema or chronic bronchitis
    ■ has difficulty in urination due to enlargement of the prostate gland
    ■ is a child with pain of arthritis

    Ask a doctor or pharmacist before use if you are
    ■ taking the blood thinning drug warfarin
    ■ taking sedatives or tranquilizers

    When using this product
    ■ do not use more than directed (see Overdose warning)
    ■ excitability may occur, especially in children
    ■ marked drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    ■ avoid alcoholic beverages
    ■ use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if
    ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    ■ fever gets worse or lasts more than 3 days
    ■ redness or swelling is present
    ■ new symptoms occur
    ■ cough comes back or occurs with 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.


    Overdose warning: Taking more than the recommended dose (overdose) may
    cause liver damage. In case of overdose, get medical help or contact a Poison
    Control Center right away. Prompt medical attention is critical for adults as
    well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ do not take more than directed (see Overdose warning)
    ■ chew thoroughly before swallowing
    ■ dose every 4 hours or as directed by a doctor

    adults and children 12 years
    of age and over
    4 chewable tablets every 4 hours, not to exceed
    6 doses (24 chewable tablets) in any 24-hour period
    children 6 to under 12 years
    of age
    2 chewable tablets every 4 hours, not to exceed
    5 doses (10 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 13 mg
    ■ Store in a cool dry place at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    NDC 72854-085-16

    Children's
    Mucinex®

    Cough Suppressant

    Antihistamine

    Acetaminophen 162.5 mg

    Dextromethorphan HBr 5 mg

    Doxylamine succinate 3.125 m

    Age 6+

    Mixed Berry Flavor

    Label

  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE3.125 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN162.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PECTIN (UNII: 89NA02M4RX)  
    POTASSIUM SODIUM TARTRATE (UNII: QH257BPV3J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize23mm
    FlavorBERRY (Mixed Berry) Imprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-085-1616 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)06/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - RB Health (US) LLC (081049410)