MedPath

AXIV Night Time - Liquid

AXIV Night Time Cold & Flu - Liquid

Approved
Approval ID

186f8519-655d-bd21-e063-6294a90a16a8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

VIVUNT PHARMA LLC

DUNS: 045829437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82706-023
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (14)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 30 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 30 mL
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 12.5 mg in 30 mL
Code: V9BI9B5YI2
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/14/2024

PRINCIPAL DISPLAY PANEL

Compare to VICKS ®NyQuil ®

Cold & Flu active ingredients*

NDC 82706-023-01

AXIV - NightTime

COLD&FLU

Multi-Symptom Relief

  • Pain Reliever
  • Fever Reducer
  • Cough Suppresant
  • Antihistamine

Nighttime Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

12 FL OZ (355 mL)

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

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/14/2024

Uses

Temporarily relieves common cold/flu symptoms:

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/14/2024

Distributed by:

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

Miami, FL 33156-3178

Made in USA

www.vivunt.live

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/14/2024

Active ingredients (in each 30 mL dose cup)

Purpose

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/14/2024

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if:

  • adults and children over 12 years of age take more than 4 doses (30 mL each) 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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.

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 serious health problems, including liver damage. 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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/14/2024

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, limit total to 4 doses per 24 hours

adults and children 12 years and over

30 mL every 6 hours

children under 12 years

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/14/2024

Other information

  • Each 30 mL dose cup contains: sodium 10 mg
  • Store at room temperature 15 - 30°C (59 - 89°F) and do not refrigerate
  • Tamper evident: Do not use if shrink band is missing or broken

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/14/2024

Inactive ingredients

Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

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