Label: SEVERE CONGESTION AND COUGH MAX- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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

  • ACTIVE INGREDIENT

    Drug Facts


    Active ingredients
    (in each 20 mL)
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose

    Dextromethorphan HBr    Cough suppressant
    Guaifenesin                     Expectorant
    Phenylephrine                 Nasal Decongestant

  • INDICATIONS & USAGE

    Uses
    ● 
    helps 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

    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 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.
    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.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • take only as recommended
    • use dosage cup
    • mL =milliliter
    • do not take more than 6 doses in any 24-hour period

    Age                                         Dose
     Adults & children 12 years and older 20 mL every 4 hours
     Children under 12 years of age Do not use

  • OTHER SAFETY INFORMATION

    Other information
    each 20 mL contains: sodium 10 mg
    dosage cup provided
    store between 15-30°C (59-86°F)
    do not refrigerate

  • INACTIVE INGREDIENT

    Inactive ingredients
    Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl
    gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

  • Maximum Strength Max Severe Congestion & Cough

    AP SAFE®                   NDC 76281-517-25

    Compare to Mucinex® FAST-MAX™ Severe Congestion
    & Cough Active ingredients*

    Maximum Strength
    Max Severe Congestion & Cough

    Dextromethorphan HBr/
    Cough Suppressant
    Guaifenesin /Expectorant
    Phenylephrine HCI / Nasal Decongestant

    Congestion& Cough

    Relief of:
    • Cough
    • Thins & Loosens Mucus
    • Nasal & Chest Congestion

    Adults- For Ages 12 and over

    6 FL OZ ( 177 mL)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

    This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Severe
    Congestion & Cough.

    517 6 Oz

    res

  • INGREDIENTS AND APPEARANCE
    SEVERE CONGESTION AND COUGH MAX 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-517
    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) PHENYLEPHRINE10 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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-517-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/30/2024
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-517)