MedPath

AXIV Sinus Severe Mucus

AXIV - Sinus Severe + Mucus

Approved
Approval ID

13245298-8b78-e177-e063-6294a90a6bec

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, Guaifenesin, Phenylephrine Hydrocloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82706-020
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Guaifenesin, Phenylephrine Hydrocloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (15)

PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GUAIFENESINActive
Quantity: 200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/12/2025

PRINCIPAL DISPLAY PANEL - AXIV Sinus Severe + Mucus 50

Compare Vicks® Sinex ™

Severe All In One Sinus + Mucus™ LiquiCaps®

active ingredients*

NDC 82706-020-04

AXIV Sinus Severe + Mucus

Cough & Congestion

Pain Reliever
Fever Reducer
Expectorant
Nassal Decongestant

NON-DROWSY

Acetaminophen, Guaifenesin, Phenylephrine HCl

50 SOFTGELS****Liquid-filled Capsules

*This product is not manufactured or distributed by

The Procter &Gamble Company, owner of the registered

trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps®

SINUS 50 SOFTGELS

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/8/2024

Uses

Temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

  • sinus congestion and pressure
  • headache
  • nasal congestion
  • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/8/2024

Distributed by:

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

Miami, Florida, 33156-3178

Made in India

www.vivunt.live

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/8/2024

Active Ingredients (in each softgel)

Purpose

Acetaminophen 325 mg

Pain reliever-Fever reducer

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 7/8/2024

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.

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
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/8/2024

Directions

  • Take only as directed (see overdose warning)
  • Do not take more than 8 softgels in 24 hours

adults and children 12 years and over

2 softgels with water every 4 hours

children 4 to under 12 years

consult a doctor

children under 4 years

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/8/2024

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 3/8/2024

Inactive ingredients

D&C Red No. 33, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.