MUCUS RELIEF CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HEALTHY ACCENTS (DZA BRANDS, LLC)]

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  • MUCUS RELIEF CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HEALTHY ACCENTS (DZA BRANDS, LLC)]

MUCUS RELIEF CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HEALTHY ACCENTS (DZA BRANDS, LLC)]
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NDC 55316-037-06
Set ID 8edb0de4-b9e5-4b29-96a3-8689d0aada19
Category HUMAN OTC DRUG LABEL
Packager Healthy Accents (DZA Brands, LLC)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    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

    • 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
    • high blood pressure
    • thyroid disease
    • 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)

    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 occur with fever
    • cough comes back, or occurs with fever, rash or headache that lasts.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 (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in a 24-hour period
    • measure only with dosing cup provided Do not use any other dosing device
    • keep dosing cup with product
    • mL=milliliter
    • shake well before using
    • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • each 20 mL contains: sodium 17 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sodium citrate, xanthan gum

  • Principal Display Panel

    *Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough

    Maximum Strength

    mucus relief

    Severe Congestion & Cough

    cough suppressant (dextromethorphan HBr)

    expectorant (guaifenesin)

    nasal decongestant (phenylephrine HCl)

    adults 12 years and over

    FL OZ (mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY: DZA BRANDS, LLC

    Salisbury, NC 28147

    Scarborough,me 04074

    For product questions or concerns, contact us at 1-866-322-2439

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCI 10 mg

    Healthy Accents Maximum Strength Mucus Relief Severe Congestion & Cough

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF CONGESTION AND COUGH  MAXIMUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-037
    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)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-037-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201612/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/201612/31/2021
    Labeler - Healthy Accents (DZA Brands, LLC) (090322194)
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