Label: CVS CHILDRENS COUGH RELIEF- dextromethorphan hydrobromide and guaifenesin liquid

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

Drug Label Information

Updated August 22, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Purpose

    Dextromethorphan HBr 5 mg

    Cough suppressant

    Guaifenesin 100 mg

    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 usein 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

    Stop use and ask a doctor ifcough 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.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    AgeDose

    children 6 years to under 12 years

    5 mL – 10 mL every 4 hours

    children 4 years to under 6 years

    2.5 mL – 5 mL every 4 hours

    children under 4 years

    do not use

  • Other information

    • each 5 mL contains: sodium 2 mg
    • Tamper evident: do not use if printed inner seal under cap is torn or missing
    • store at room temperature
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red #40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Compare to the Active Ingredients in Children’s Mucinex ®cough

    NDC 69842-577-04

    Children's Cough Relief

    Dextromethorphan HBr , 5 mg

    Guaifenesin,100 mg

    Natural CherryF lavor

    Dosage Cup Included

    Ages 4 + years

    Controls Cough
    Relieves Chest Congestion
    Breaks up Mucus

    4 FL OZ(118 mL)

    *This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex ®Cough.

    IMPORTANT: Keep this carton for future reference on full labeling.

    Children's Mucus and Cough Relief 4 FL OZ Cherry Flavor
  • INGREDIENTS AND APPEARANCE
    CVS CHILDRENS COUGH RELIEF 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-577
    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)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-577-041 in 1 CARTON03/14/2022
    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 DrugM01203/14/2022
    Labeler - CVS PHARMACY, INC (062312574)