Label: AXIM NIGHT TIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

  • NDC Code(s): 82706-002-01, 82706-002-02
  • 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 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Doxylamine succinate 6.25 mgAntihistamine
  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
    • runny nose & sneezing
  • Warnings

    Liver warning

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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
    • to make a child sleep

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    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.

    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 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

    • Take only as directed see - overdose warning:
    • Do not take more than 8 Softgels in 24 hours.

    adults & children 12 yrs & over2 Softgela with water every 6 hrs
    children 4 to under 12 yrsconsult a doctor
    children under 4 yrsdo not use
  • Other information

    • Store at 20° - 25 °C (68 °- 77 °F)
    • Read all product information before using
    • Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.
  • Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, 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 24

    Compare to VICKS ® NyQuil ®

    Cold & Flu LiquiCaps®

    active ingredients*

    NDC 82706-002-01

    • Pain Reliever
    • Fever Reducer
    • Cough Suppresant
    • Antihistamine

    Nighttime Relief

    Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

    24 LiquiCaps** **Liquid-filled capsules

    Axim Night Time

  • PRINCIPAL DISPLAY PANEL

    Compare to VICKS ® NyQuil ®

    Cold & Flu LiquiCaps®

    active ingredients*

    NDC 82706-002-02

    Pain Reliever
    Fever Reducer
    Cough Suppresant
    Antihistamine

    Nighttime Relief

    Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

    6 LiquiCaps** **Liquid-filled capsules

    Nightt

  • INGREDIENTS AND APPEARANCE
    AXIM NIGHT TIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-002
    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 HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-002-0124 in 1 CARTON05/09/2022
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:82706-002-023 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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