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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 4, 2017

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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

  • 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 finalpart34108/04/2016
    Labeler - Discount Drug Mart (047741335)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53943-512)
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