Label: MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- mucinex congestion and cough maximum strength 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 November 4, 2013

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  • Drug Facts

    Dextromethorphan HBr 20mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10mg

  • Purpose

    Dextromethorphan............................Cough suppressant

    Guaifenesin................................Expectorant

    Phenylephrine HCL..........................Nasal Decongestant

  • Uses

    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 you get to sleep, helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • warnings

    for children under 12 years of age

  • Do not use

    if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Ask a doctor before use if you have

    persistent or chronic cough such as occurs with smoking, astha, chrinic bronchitis or emphysema

    cough that occurs with too much phlegm (mucus)

  • when using this product

    do not use more than directed

  • stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

  • If pregnant or breast feeding

    ask a health professional before use.

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    do not exceed recommended dosage

    use dosage cup provided

    do not take more than 6 doses in a 24 hour period

    do not use dosing cup with other products

    dose as follows or as directed by a doctor mL=milliliter

    children under 12 years-do not use

    adults and children 12 years and older-20mL every 4 hours

  • Other information

    each 20mL contains potassium 6mg, sodium 13mg

    store at room temperature

    do not refrigerate

  • Inactive ingredients

    citric acid, dextrose, flavors, glycerin, methyl paraben, potassium sorbate, propylene glycol, propyl paraben, purified water, red 33, red 40, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

  • Principal Display Panel

    Maximum Strength

    Mucus Relief

    Severe Congestion and Cough

    Cought Suppressant

    (Dextromethorphan HBr)

    Chest Congestion and Mucus

    (Guaifenesin)

    Stuffy Nose

    (Phenylephrine HCl)

    Mucus, Stuffy Nose, Chest Congestion, Cough

    For Ages 12 and over

    Distrubted By AmerisourceBergen

    1300 Morris Drive Chesterbrook PA 19087

    Visit us at www.goodneighborpharmacy.com

    Questions or comments? 1 866 534 4631

    6 fl oz 177 mL

     image description

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
    mucinex congestion and cough maximum strength liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-219
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-219-30177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/04/2013
    Labeler - Good Neighbor Pharmacy (007914906)
    Registrant - Aaron Industries, Inc. (113044205)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aaron Industries, Inc.113044205manufacture(46122-219) , analysis(46122-219)
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