Label: AXIM DAY AND NIGHT TIME 48 SOFTGELS- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate kit
AXIM DAY AND NIGHT TIME 72 SOFTGELS- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate kit

  • NDC Code(s): 82706-003-01, 82706-004-01
  • 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 May 11, 2022

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

  • SPL UNCLASSIFIED SECTION

    Day Time

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose
    Acetaminophen 325 mg

    Pain Reliever-fever reducer

    Dextrometrophan HBr 10 mgCough Suppressant
    Phenylephrine HCl 5 mgNasal Decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • Nasal Congestion
    • 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 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.

    Sore throat warning

    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
    • heart disease
    • high blood pressure
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • 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.

    When using this product

    do not exceed recommended dose

    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


    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 years

    2 Softgels with water every 4 hours

    Children 4 to under 12 years

    consult 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 the foil printed on the blister is torn or ripped.
  • 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

    Night Time

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose

    Acetaminophen 325 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 15 mg

    Cough suppressant
    Doxylamine succinate 6.25 mg Antihistamine

  • 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 4000 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.

    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

    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 and children over 12 years2 Softgels with water every 6 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 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 - 48 Caps Day&Night

    Compare to Vicks ® DayQuil ® & NyQuil ®

    Cold&Flu LiquiCaps®
    active ingredients*
    NDC 82706-003-01

    Day Time

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

    Acetaminophen , Phenylephrine HCl, Dextromethorphan HBr

    32 SOFTGELS** **Liquid-filled capsules



    Night Time

    • Headache, Fever, Sore Throat, Minor Aches & Pains
    • Sneezing, Runny Nose
    • Cough

    Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

    16 SOFTGELS** **Liquid-filled capsules

    Axim Day and Night 48 caps

  • PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night

    Compare to Vicks ® DayQuil ® & NyQuil ®

    Cold&Flu LiquiCaps®
    active ingredients*
    NDC 82706-004-01

    Day Time

    Pain Reliever
    Fever Reducer
    Cough Suppressant
    Nasal Decongestant

    Acetaminophen , Phenylephrine HCl, Dextromethorphan HBr

    48 SOFTGELS** **Liquid-filled capsules



    Night Time

    Headache, Fever, Sore Throat, Minor Aches & Pains
    Sneezing, Runny Nose
    Cough

    Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

    24 SOFTGELS** **Liquid-filled capsules

    Axim Day and Night 72 caps

  • INGREDIENTS AND APPEARANCE
    AXIM DAY AND NIGHT TIME 48 SOFTGELS 
    acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-003
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-003-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package05/09/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 32 
    Part 22 BLISTER PACK 16 
    Part 1 of 2
    AXIM DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:82706-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Part 2 of 2
    AXIM NIGHT TIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:82702-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    AXIM DAY AND NIGHT TIME 72 SOFTGELS 
    acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-004
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-004-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package05/09/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 BLISTER PACK 48 
    Part 23 BLISTER PACK 24 
    Part 1 of 2
    AXIM DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:82706-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Part 2 of 2
    AXIM NIGHT TIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:82702-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Labeler - VIVUNT PHARMA LLC (045829437)