Label: CHILDRENS COUGH- dextromethorphan hbr, guaifenesin liquid

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

Drug Label Information

Updated December 20, 2024

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

  • ACTIVE INGREDIENTS (in each 5 mL)

    Dextromethorphan HBr 5 mg
    Guaifenesin 100 mg

  • PURPOSE

    Cough suppressant
    Expectorant

  • USE(S)

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

    .

  • 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 YOU HAVE

    • persistent or chronic cough such as occurs with asthma 
    • cough that occurs with too much phlegm (mucus)

  • STOP USE AND A ASK DOCTOR IF

    •  cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. 

  • 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
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • mL=milliliter


    Age  Dose
     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: potassium 5 mg, sodium 5 mg
    • store between 20 to 25°C (68 to 77°F)
    • do not refrigerate
    • dosing cup provided
  • INACTIVE INGREDIENTS

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

  • QUESTIONS?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-773-03

    equate
    Compare to Children's Mucinex® Cough active ingredients*
    children's 
    COUGH LIQUID
    Dextromethorphan HBr 5mg
    Cough Suppressant

    Guaifenesin 100 mg

    Expectorant

    AGES 4 TO 12 YEARS


    • Controls cough
    • Thins and Loosens Mucus
    • Relieves chest congestion
    • Non-Drowsy
    • Alcohol Free

    Cherry Flavored

    4 FL OZ (118 mL)





    552-Equate-4
  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-773
    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, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    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)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-773-031 in 1 CARTON08/01/2017
    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 DrugM01208/01/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(49035-773)