MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENSIN) LIQUID [H E B]

MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENSIN) LIQUID [H E B]
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NDC 37808-594-04
Set ID 9ba5ca1b-2e3c-439e-8887-c26f144b88ef
Category HUMAN OTC DRUG LABEL
Packager H E B
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help your child get to sleep
  • 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 taking 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

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • shake well before using
    age dose 
     children 6 to under 12 years  5-10 mL every 4 hours 
     children 4 to 5 years 2.5-5 mL every 4 hours
     children under 4 years do not use

  • Other information

    • each 5 mL contains: sodium 2 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

  • Questions or comments?

     Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Children's Mucinex® Cough active ingredients*

    Children's Mucus Relief Cough

    Dextromethorphan HBr 5 mg / Cough Suppressant

    Guaifenesin 100 mg / Expectorant

    Cough Relief

    For Ages 4 to 11 Years

    Alcohol-Free

    Relief of:

    • Cough
    • Chest Congestion
    • Mucus

    CHERRY FLAVOR

    FL OZ (mL)

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

    TAMPER EVIDENT:  DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    MADE WITH PRIDE AND CARE FOR

    H-E-B®, SAN ANTONIO, TX 78204

  • Package Label

    Dextromethorphan HBr 5 mg, Guaifenesin 100 mg

    H-E-B Children's Mucus Relief Cough

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COUGH  CHILDRENS
    dextromethorphan hbr, guaifensin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-594
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-594-041 in 1 BOX07/31/2016
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2016
    Labeler - H E B (007924756)

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