Label: CHILDRENS MUCINEX MULTI-SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

  • 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 August 31, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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
    AgeDose
    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


    1
    may contain this ingredient
  • Questions?

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

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

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

    Made in England

  • PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

    VALUE SIZE!

    NDC 63824-282-67

    Children's
    Mucinex®

    Multi-Symptom
    Cold

    Cough Suppressant
    Expectorant
    Nasal Decongestant

    Dextromethorphan HBr 5 mg
    Guaifenesin 100 mg
    Phenylephrine HCl 2.5 mg

    Stuffy Nose
    Cough
    Chest Congestion
    Breaks up Mucus

    Age 4+

    Very Berry
    Flavor Liquid

    6.8 FL OZ
    (201 mL)

    Principal Display Panel - 201 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCINEX MULTI-SYMPTOM COLD 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-282
    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
    ColorPINKScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-282-671 in 1 CARTON07/17/2012
    1201 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:63824-282-641 in 1 CARTON07/17/2012
    2118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NDC:63824-282-222 in 1 CELLO PACK07/17/2012
    31 in 1 CARTON
    3118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/17/2012
    Labeler - Reckitt Benckiser LLC (094405024)