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

  • NDC Code(s): 55319-204-45
  • Packager: Family Dollar Services Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 2024

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep
      • nasal congestion due to a cold
  • 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.

    Ask a doctor before use if you have

    • difficulty in urination due to enlargement of the prostate gland
    • heart disease
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
    • diabetes
    • thyroid disease

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not get better within 7 days or occur with fever
    • cough persists more than 7 days, tends to recur, or is accompanied by a 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not take more than directed
    • do not take more than 6 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
    • children under 12 years: do not use
  • Other information

    • each 20 mL contains: sodium 9 mg
    • use by expiration date on package
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    FAMILY
    Wellness™

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

    MAXIMUM STRENGTH
    SEVERE CONGESTION
    & COUGH

    Dextromethorphan HBr
    Guaifenesin
    Phenylephrine HCl

    Cough Suppressant
    Expectorant
    Nasal Decongestant

    • Controls Cough
    • Relieves Nasal & Chest Congestion
    • Thins & Loosens Mucus

    AGES
    12 YEARS
    & OVER

    6 FL OZ
    (177 mL)

    NDC 55319-204-45

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    *This product is not manufactured or distributed by RB Health (US)
    LLC, owner of the registered trademark Mucinex® FAST-MAX®
    Severe Congestion & Cough.
    50844       ORG042300445

    DISTRIBUTED BY: MIDWOOD BRANDS LLC,
    500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
    NOT 100% SATISFIED?
    Return within 30 days to the store of purchase
    for a refund (with receipt) or exchange.

    Family Wellness 44-004

    Family Wellness 44-004

  • INGREDIENTS AND APPEARANCE
    SEVERE CONGESTION AND COUGH 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-204
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-204-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/04/2024
    Labeler - Family Dollar Services Inc (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(55319-204) , pack(55319-204)
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