Label: AXIV DAYTIME- acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

  • NDC Code(s): 82706-015-01, 82706-015-02, 82706-015-03
  • Packager: VIVUNT PHARMA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose
    Acetaminophen 325 mgPain Reliever/Fever Reducer
    Dextromethorphan HBr 10 mgCough Suppressant
  • Uses

    Temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
  • Warnings

    Liver warning

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

    • more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    Sore throat warning

    If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema

    When using this product

    do not exceed recommended dose

    Stop use and ask a doctor if

    • pain 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

    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 12 years and over2 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.
    • Tamper evident: Do not use if carton or pouch is open
  • Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

  • SPL UNCLASSIFIED SECTION


    Distributed by:

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

    Miami, Florida, 33156-3178

    Made in India

    www.vivunt.live

  • PRINCIPAL DISPLAY PANEL AXIV DayTime Carton 24 ​AXIV DayTime Carton 100

    Compare to

    VICKS ® DayQuil®

    Cold&Flu LiquiCaps®

    active ingredients*

    NDC 82706-015-01

    AXIV - DayTime

    COLD&FLU

    Multi-Symptom Relief

    • Pain Reliever
    • Fever Reducer
    • Cough Suppressant
    • Nasal Decongestant


    Non-Drowsy

    Acetaminophen, Dextromethorphan HBr

    24 SOFTGELS** **Liquid-filled capsules

    *This product is not manufactured or distributed by

    The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®

    and LiquiCaps®.

    AXIV1DAY

    Compare to

    VICKS ® DayQuil®

    Cold&Flu LiquiCaps®

    active ingredients*

    NDC 82706-015-03

    AXIV - DayTime

    COLD&FLU

    Multi-Symptom Relief

    Pain Reliever
    Fever Reducer
    Cough Suppressant


    Non-Drowsy

    Acetaminophen, Dextromethorphan HBr

    100 SOFTGELS** **Liquid-filled capsules

    *This product is not manufactured or distributed by

    The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®

    and LiquiCaps®.

    Day Time AXIV 100 softgels

  • INGREDIENTS AND APPEARANCE
    AXIV DAYTIME 
    acetaminophen, dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code AXIV
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-015-013 in 1 CARTON03/07/2024
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:82706-015-022 in 1 CARTON03/07/202403/07/2024
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:82706-015-0350 in 1 CARTON07/05/2024
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/07/2024
    Labeler - VIVUNT PHARMA LLC (045829437)
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