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

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

Drug Label Information

Updated January 31, 2024

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

  • 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 in a 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)