Label: CHILDRENS COUGH- dextromethorphan 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 July 31, 2018

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)



    773

  • 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 FINALpart34108/01/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)