Label: AXIM DAYTIME - LIQUID- acetaminophen, dextromethorphan hydrobromide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL dose cup)Purpose
    Acetaminophen 655 mgPain reliever/fever reducer
    Dextromethorphan HBr 20 mgCough suppressant
  • Uses

    Temporarily relieves common cold/flu symptoms:

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

    Liver warning

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

    • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
    • taken with other drugs containing acetaminophen
    • adult has 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

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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

    When using this product

    do not exceed recommended dose

    Keep out of reach of children.

    If pregnant or breast-feeding

    ask a health professional before use.

    Overdose warning

    Taking more than the recommended dose (overdose) could cause seriuos health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed (see overdose warning)
    • measure only with dosage cup provided and keep dosage cup with product
    • mL = milliliter
    • do not exceed 4 doses per 24 hours
    • when using DayTime and NightTime products, carefully read each label to ensure correct dosing

    adults and children 12 years and over30 mL every 4 hours
    children under 12 yearsdo not use
  • Other information

    • Each 30 mL dose cup contains: sodium 10 mg
    • Store at room temperature 15 - 30°C (59 - 86°F) and do not refrigerate
    • Tamper evident: Do not use if shrink band is missing or broken
  • Inactive ingredients

    Citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

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

    Miami, FL 33156-3178

    Made in USA

    www.vivunt.live

  • PRINCIPAL DISPLAY PANEL

    Compare to

    VICKS ® DayQuil®

    Cold&Flu active ingredients*

    NDC 82706-011-01

    AXIM - DayTime

    COLD&FLU

    Multi-Symptom Relief

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

    Non-Drowsy

    Acetaminophen, Dextromethorphan HBr

    12 FL OZ (355 mL)

    *This product is not manufactured or distributed by The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®.

    ADL

  • INGREDIENTS AND APPEARANCE
    AXIM DAYTIME - LIQUID 
    acetaminophen, dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-011-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/05/2024
    Labeler - VIVUNT PHARMA LLC (045829437)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rnv LLC118917568manufacture(82706-011)