Label: MAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX- 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 31, 2020

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  • Drug FactsActive ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

    Phenylephrine HCL, USP 10 mg

  • Purpose

    Cough Suppressant

    Expectorant

    Naasal 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

    • help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occuring with a cold:
    • cough due to minor throat and bronchial irritation
    • nasal congestion
  • Warnings

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

    Do not use

    • for children under 12 years of age
    • 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.
  • 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 dosage cup
    • mL = milliliter
    • do not take more than 6 doses in any 24-hour period
     Age Dose
     Adults and children 12 years and older 20 mL every 4 hours
     Children under 12 years of age Do not use

  • Other information

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

    Anhydrous citric acid, edetate disodium, FD and C Blue # 1, FD and Red # 40, glycerin, 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

  • DISCOUNT drug mart FOOD FAIR MAXIUM STRENGTH SEVERE CONGESTION & COUGH MAX product label

    *COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™ SEVERE CONGESTION AND COUGH

    LF-011

    DISCOUNT

    drug mart

    FOOD FAIR

    MAXIUM STRENGTH SEVERE CONGESTION & COUGH MAX

    Dextromethorphan HBr/ Guaifenesin / Phenylephrine HCL

    COUGH SUPPRESSANT/

    EXPECTORANT/

    NASAL DECONGESTANT

    Controls Cough

    Thins & Loosens mucus

    Relieves Nasal & Chest Congestion

    Adults

    For Ages 12 & Over

    6 FL OZ (177 mL)

    * This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of MUCINEX® FAST-MAX™ SEVERE CONGESTION AND COUGH

    LB - 011 LOT: EXP:

    Peel Corner to Read Complete Drug Facts and Information

    SATISFACTION GUARANTEED
    IF DISSASIFIED , RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    AptaPharma 517 DPL

    AptaPharma 517 DPL1

  • INGREDIENTS AND APPEARANCE
    MAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-517
    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) 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:53943-517-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/10/2013
    Labeler - Discount Drug Mart (047741335)
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