Label: CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR- dextromethorphan hydrobromide, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 26, 2025

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active ingredients
    (in each 5 mL teaspoonful)
    Dextromethorphan HBr, USP 5 mg
    Guaifenesin, USP 100 mg

  • PURPOSE

    Purpose
    Dextromelhorphan HBr, USP ....... Cough Suppressant
    Guaifenestn,USP ........................Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves:cough due to minor throat and bronchial irritation as may occur with a cold 

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tube

  • WARNINGS

    Warnings
    Do not use ina child who is 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 child's prescription drug
    contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma

    When using this product•do not use more than directed

    Stop use and ask a doctor if
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.In case of overdose, get
    medical help or contact a Poison Control Center right
    away.

  • DOSAGE & ADMINISTRATION

    Directions
    •do not take more than 6 doses in any 24-hour period

                                      Age                                                                                            Dose

    Children 6 years to
    Under 12 years     		1 to 2 teaspoonfuls (tsps)
    every 4 hours
    Children 4 years to
    Under 6 years     		1/2 to 1 teaspoonful (tsp)
    every 4 hours
    Children under 4 yearsdo not use

  • OTHER SAFETY INFORMATION

    Other information• each teaspoon contains: sodium 3 mg

    •store between 20-25°C (68-77°F) •do not refrigerate

    •dosing cup provided • Keep carton for full direction for use

  • INACTIVE INGREDIENT

    Inactive ingredients:anhydrous citric acid, dextrose, D&C red
    #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol,
    purified water, saccharin sodium, sodium benzoate, sucralose,
    xanthan gum

  • QUESTIONS

    Questions?Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

  • CHILDREN'S MUCUS RELIEF COUGH CHERRY

    AP SAFE                        NDC 76281-512-24

    Children's                                        
    Cough
    Mucus Relief

    Cough Suppressant
    Expectorant

    Cherry Flavor
    4 FL OZ (118 mL)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by
    Reckitt Benckiser Inc., distributor of Children's
    Mucinex®Cough.

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

    512 Cartn

    512 Botl

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-512
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-512-241 in 1 CARTON01/30/2024
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/30/2024
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-512)
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