Label: AXIM SINUS SEVERE MUCUS- acetaminophen, guaifenesin, phenylephine hcl capsule, liquid filled

  • NDC Code(s): 82706-006-01, 82706-006-02
  • Packager: VIVUNT PHARMA LLC
  • 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 September 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each softgel)Purpose

    Acetaminophen 325 mg

    Pain reliever-Fever reducer

    Guaifenesin 200 mg

    Expectorant
    Phenylephrine HCl 5 mg

    Nasal decongestant

  • Uses

    Temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever
  • Warnings

    Liver warning

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy Alert:

    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.

    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.
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • 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)

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dose

    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 headache that lasts

    These could be signs of a serious condition

    Keep out of reach of children.

    If pregnant or breast-feeding

    ask a health professional before use.

    Overdose warning

    In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

  • Directions

    • Take only as directed (see overdose warning)
    • Do not take more than 8 softgels in 24 hours

    adults and children over 12 years2 softgels with water every 4 hours
    children 4 to under 12 yearsconsult a doctor
    children under 4 yearsdo not use
  • Other information

    • Store at 20° - 25 °C (68 °- 77 °F)
    • Read all product information before using
    • Tamper Evident: Do not use if carton is open or blister unit is broken.
  • Inactive ingredients

    D&C Red No. 33, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

  • SPL UNCLASSIFIED SECTION

    Product of India

    Distributed by:

    VIVUNT PHARMA LLC
    8950 SW 74th. Court. Suite 1901

    Miami, Florida. Z.C. 33156-3178

  • PRINCIPAL DISPLAY PANEL - AXIM Sinux Severe + Mucus 24

    Compare Vicks ® Sinex ™

    Severe All In One Sinus + Mucus™ LiquiCaps®

    active ingredients*

    NDC 82706-006-01

    AXIM Sinus Severe + Mucus

    Cough & Congestion

    • Pain Reliever
    • Fever Reducer
    • Expectorant
    • Nassal Decongestant

    NON-DROWSY

    Acetaminophen, Guaifenesin, Phenylephrine HCl

    24 SOFTGELS** **24 Liquid-filled Capsules

    *This product is not manufactured or distributed by

    The Procter &Gamble Company, owner of the registered

    trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps®

    Sinus Severe Mucus

  • PRINCIPAL DISPLAY PANEL - AXIM Sinux Severe + Mucus 6

    Compare Vicks® Sinex ™

    Severe All In One Sinus + Mucus™ LiquiCaps®

    active ingredients*

    NDC 82706-006-02

    AXIM Sinus Severe + Mucus

    Cough & Congestion

    Pain Reliever
    Fever Reducer
    Expectorant
    Nassal Decongestant

    NON-DROWSY

    Acetaminophen, Guaifenesin, Phenylephrine HCl

    6 SOFTGELS** **24 Liquid-filled Capsules

    *This product is not manufactured or distributed by

    The Procter &Gamble Company, owner of the registered

    trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps®

    Sinus

  • INGREDIENTS AND APPEARANCE
    AXIM SINUS SEVERE MUCUS 
    acetaminophen, guaifenesin, phenylephine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-006-012 in 1 CARTON05/09/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:82706-006-023 in 1 CARTON09/20/2023
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Labeler - VIVUNT PHARMA LLC (045829437)
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