Label: CHILDRENS MUCINEX CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

  • 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 October 29, 2013

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


    Drug Facts


    Active ingredients (in each 5 mL)Purposes
    Dextromethorphan HBr 5 mgCough suppressant
    Guaifenesin 100 mgExpectorant
    Phenylephrine HCl 2.5 mgNasal decongestant
  • 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
      • nasal congestion due to a cold
      • stuffy nose
  • 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • persistent 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

    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with 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
    • dose as follows or as directed by a doctor
    • mL = milliliter
    children 6 years to under 12 years10 mL every 4 hours
    children 4 years to under 6 years5 mL every 4 hours
    children under 4 yearsdo not use
  • Other information

    • each 5 mL contains: sodium 3 mg
    • tamper evident: do not use if neckband on bottle cap is broken or missing
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

    may contain this ingredient
  • Questions?

    1-866-MUCINEX (1-866-682-4639)

    You may also report side effects to this phone number.


    Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

    Made in England

  • PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

    NDC 63824-283-67


    & Cough

    Dextromethorphan HBr 5 mg      Cough Suppressant
    Guaifenesin 100 mg                      Expectorant
    Phenylephrine HCl 2.5 mg           Nasal Decongestant

    Chest Congestion
    Breaks up Mucus
    Stuffy Nose

    Age 4+

    Flavor Liquid

    6.8 FL OZ
    (201 mL)

    Principal Display Panel - 201 mL Bottle Carton
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-283
    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
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propyl gallate (UNII: 8D4SNN7V92)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    FlavorBERRYImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-283-671 in 1 CARTON
    1201 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/17/2012
    Labeler - Reckitt Benckiser LLC (094405024)