H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]

H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]
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NDC 37808-317-25
Set ID d2b016ee-5329-45bf-9d71-d626204169cf
Category HUMAN OTC DRUG LABEL
Packager H E B
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients

    Drug Facts

    Active ingredients  (in each 20 mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCL 10 mg

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  • Purpose

    Cough suppressant
    Expectorant
    Nasal Decongestant

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  • 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.

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  • 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
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  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)
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  • When using this product

    • do not use more than directed
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  • 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.
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  • If pregnant or breast feeding,

    ask a health professional before use.

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  • Directions

    Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

    Age - Children under 12 years of age                  Dose - Do not use

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

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  • Other information

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

    anhydrous citric acid, 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

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  • Questions?

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

    1-877-798-5944

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  • 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

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  • Product Label

    Compare to MUCINEX® FAST-MAX™, Severe Congestion and Cough active ingredients*

    NDC 37808-317-25

    H-E-B®

    MAX SEVERE CONGESTION AND COUGH

    Maximum Strength

    Dextromethorophan HBr
    (Cough Suppressant)

    Guaifenesin
    (Expectorant)

    Phenylephrine HCL
    (Nasal Decongestant)

    Controls Cough
    Thins and Loosens Mucus
    Relieves Nasal and Chest Congestion

    6 FL OZ (177mL)

    Adults
    For Ages 12 and Over

    *This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Severe Congestion and Cough.

    MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TEXAS, 782044

    GUARANTEE

    We believe the high quality of the H-E-B product makes an outstanding value. We hope you'll agree. If not, we'll cheerfully refund your money. Thanks for shopping with us.

    Peel Corner to Read Complete Drug Facts and Information

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



    LF-001   1208

    Lot:
    Exp


    AptaPharma HEBMaxSevere Label


    AptaPharma HEBMaxSevere2 Label

    AptaPharma HEBMaxSevere1 Label

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  • INGREDIENTS AND APPEARANCE
    H E B MAX SEVERE CONGESTION AND COUGH  MAXIUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-317
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-317-25 177 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/14/2012
    Labeler - H E B (007924756)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    Name Address ID/FEI Business Operations
    AptaPharma Inc. 790523323 manufacture(37808-317)
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