Label: SEVERE CONGESTION AND COUGH MAX MAXIUM STRENGTH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • NDC Code(s): 68016-221-00
  • Packager: Chain Drug Consortium, LLC
  • 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 December 30, 2020

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

  • Active ingredients

    Drug Facts

    Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCL 10 mg

  • Purpose

    Cough suppressant
    Expectorant
    Nasal Decongestant

  • Keep out of reach of children

    Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control center right away.

  • Uses

    • helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

    • temporarily relieves these symptoms occurring with a cold:
    • cough due to minor throat and bronchial irritation
    • nasal congestion
  • Warnings

    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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
    • for children under 12 years of age
  • Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic 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

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not get better within 7 days or are accompanied by a fever
    • cough 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.

  • Directions

    • take only as recommended
    • use dose cup
    • mL = milliliter
    • do not take more than 6 doses in any 24-hour period
    AptaPharmaPVSevereCongCouMax3 Label
  • Other information

        each 20 mL teaspoon contains:

    • sodium 10 mg
    • dosage cup provided
    • store between 15-30 ° C (59-86° F)
    • do not refrigerate
  • Inactive ingredients

    citric acid anhydrous, edetate disodium, FD and C Blue # 1 FD and C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

     1-877-798-5944

  • Product Label

    NDC 68016-221-00
    *COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™  SEVERE CONGESTION AND COUGH LF-004

    Premier Value®

    Maximum Strength
    Severe Congestion and Cough MAX

    Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL
    COUGH SUPPRESSANT / EXPECTORANT/ NASAL DECONGESTANT


    • Controls Cough
    • Thins and Loosens Mucus
    • Relieves Nasal and Chest Congestion


    Adults

    For Ages 12 and Over

     6 FL OZ (177mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Peel Corner to read Complete Drug Facts and Information     

    Lot:    Exp:

    *This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® FAST-MAX™  DM MAX

    If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431


    LF-004


    AptaPharmaPV SevereCongCoulMAX Label


    AptaPharmaPV SevereCongCoulMAX1 Label

    AptaPharmaPV SevereCongCoulMAX2 Label

  • INGREDIENTS AND APPEARANCE
    SEVERE CONGESTION AND COUGH MAX  MAXIUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-221-00177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2013
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-221)