MUCUS RELIEF COLD, FLU, AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HEALTHY ACCENTS (DZA BRANDS, LLC)]

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  • MUCUS RELIEF COLD, FLU, AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HEALTHY ACCENTS (DZA BRANDS, LLC)]

MUCUS RELIEF COLD, FLU, AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HEALTHY ACCENTS (DZA BRANDS, LLC)]
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NDC 55316-336-06
Set ID 5b99c3d0-5a76-4860-b7dc-791f29c74f3b
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)

    Acetaminophen 650 mg 

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer 

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • sinus congestion and pressur
      • minor aches and pains 
      • nasal congestion 
      • cough due to minor throat and bronchial irritation 
      • sore throat 
      • headache
    • temporarily reduces fever
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 6 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor pro

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

    • liver disease
    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • 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)

    Ask a doctor or pharmacist before use if you are

     taking the blood thinning drug warfarin.

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • pain nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with 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.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see overdose warning)
    • do not take more than 6 doses in any 24-hour period
    • measue only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • mL = milliliter
    • 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 12 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

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

  • Principal Display Panel

    *Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu, & Sore Throat

    maximum strength mucus relief

    Cold, Flu & Sore Throat

    pain reliever • fever reducer (Acetaminophen)

    cough suppressant (dextromethorphan HBr)

    expectorant (Guaifenesin)

    nasal decongestant (phenylephrine HCI)

    adults 12 years and over

    FL OZ (mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max® Maximum Strength Cold Flu & Sore Throat.

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

    DISTRIBUTED BY: DZA BRANDS, LLCS

    Salisbury, NC 28147

    Scarborough, ME 04074

    For product questions or concerns, contact us at 1-866-322-2429.

  • Package Label

    Acetaminophen 650 mg, Dextromethorphan HBr 20mg, Guaifenesin 400 mg, Phenylephrine HCI 10 mg

    Healthy Accents Maximum Strength Mucus Relief Cold, Flu, & Sore Throat

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COLD, FLU, AND SORE THROAT  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-336
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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:55316-336-06177 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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