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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

    Uses
    • helps loosen phlegm (mucus)
    and thin bronchial secretions to
    drain bronchial tubes
    • temporarily relieves these
    symploms 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
    oxiclase 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 DOCTOR

    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

    When using this product
    • do not use more than
    directed

  • STOP USE

    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 &               20 ml every 4
    children 12               hours
    years and
    older

    Children               Do not use
    under 12
    years of age

  • 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 cilric 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 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Product Label

    Compare to Mucinex® FAST-MAX™

    Severe Congestion and Cough active ingredients*

    NDC 37808-317-25

    H-E-B®

    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 & Over

    6 FL OZ (177mL)

    LF 001 Rev.01

    MADE WITH PRIDE AND CARE FOR H-E-B®

    SAN ANTONIO, TEXAS, 782044

    Peel Corner to Read Complete
    Drug Facts and Information →

    DO NOT USE IF PRINTED SEAL

    UNDER CAP IS TORN OR MISSING

                 H-E-B®

    100%
    GUARANTEE
    promise

    If you aren't completely pleased
    with this product, we'll be happy to
    replace it or refund your money.
    You have our word on it.


    LB·001 Rev.01
                1208
    8581-1711

    0 41220 38704 5

    Lot:
    Exp:

    *This product is not manufactured or
    distributed by Reckill Benckiser Inc..
    distributor of Mucinex® FAST-MAXTM
    Severe Congeslion &Cough

    MADE WITH PRIDE & CARE FOR H·E-B®
    SAN ANTONIO. TX 78204

    37808-317

    res

  • INGREDIENTS AND APPEARANCE
    H E B MAX SEVERE CONGESTION AND COUGH  MAXIUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-317
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-317-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product09/14/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/14/2012
    Labeler - H E B (007924756)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(37808-317)