Label: CHILDRENS COUGH MUCUS RELIEF- dextromethorphann hbr, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 2023

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  • Drug FactsActive ingredients(in each 5 mL teaspoonful)

    Dextromethorphan HBr, USP 5 mg
    Guaifenesin, USP 100 mg

  • Purpose

    Cough suppressant
    Expectorant

  • 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 tubes
  • 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)
    • persistant 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 persistant  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

  • Directions

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

    age                                                                   dose

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

  • Other information

    • each teaspoonful contains sodium 3 mg
    • store between20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided
    • Keep carton for full direction for use
  • 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?

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

  • Children's Cough Mucus Relief product label

    DISCOUNT
    drug
    mart
    FOOD FAIR

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

    COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*

    Children's Cough Mucus Relief

    Cough Suppressent

    Expectorant

    Dextromethorphan HBr 5 mg

    Guaifensin 100 mg

    Relieves Chest Congestion

    Thins & Loosens Mucus

    Alcohol free
    for ages 4 to 12

    CHERRY FLAVOR

    4 FL OX (118 ml)

    * this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    BX-052

    AptaPharmDD Child CoughMucus

    AptaPharmDD Child CoughMucus 1

    res

    AptaPharmDD Child CoughMucus

    AptaPharmDD Child CoughMucus 1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH MUCUS RELIEF 
    dextromethorphann hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-512
    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
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-512-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/04/2016
    Labeler - Discount Drug Mart (047741335)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53943-512)