FDA.reportPublic FDA data

AXIM Sinus Severe Mucus

Manufacturer
VIVUNT PHARMA LLC
Effective date
2024-06-14
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:00:40

Label at a glance#

ProductAXIM Sinus Severe Mucus
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure9 sections

Indications and 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

Dosage and administration

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 years do not use

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each softgel)Purpose

Acetaminophen 325 mg

Pain reliever-Fever reducer

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 4 hours
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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 - AXIM Sinux Severe + Mucus 24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare Vicks ® Sinex ™

Severe All In One Sinus + Mucus™ LiquiCaps®

active ingredients*

NDC 82706-006-01

AXIM Sinus Severe + Mucus

Cough & Congestion

  • Pain Reliever
  • Fever Reducer
  • Expectorant
  • Nassal Decongestant

NON-DROWSY

Acetaminophen, Guaifenesin, Phenylephrine HCl

24 SOFTGELS** **24 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 Severe MucusSinus Severe Mucus

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-006AXIM SINUS SEVERE MUCUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHINE HCL) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC]12Legacy NDC20240616_de9eb2d5-ba54-4637-e053-2995a90a0451.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-00682706-006-01, 82706-006-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
POVIDONE K30U725QWY32XIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
FD&C RED NO. 40WZB9127XOAIACT
GUAIFENESIN495W7451VQACTIB
D&C RED NO. 339DBA0SBB0LIACT
GELATIN2G86QN327LIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3ccdf28a-3474-63c7-e063-6394a90a3a88de9eb2d5-ba54-4637-e053-2995a90a04512025-08-20WarningsExact identifier
spl set id: de9eb2d5-ba54-4637-e053-2995a90a0451

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.