Label: H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 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 December 16, 2019

If you are a consumer or patient 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 finalpart34109/14/2012
    Labeler - H E B (007924756)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(37808-317)