AXIM SINUS SEVERE MUCUS- acetaminophen, guaifenesin, phenylephine hcl capsule, liquid filled 
VIVUNT PHARMA LLC

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AXIM - Sinus Severe + Mucus

Drug Facts

Active Ingredients (in each softgel)Purpose

Acetaminophen 325 mg

Pain reliever-Fever reducer

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

Uses

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

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.

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.

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

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

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

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

Compare Vicks ® Sinex ™

Severe All In One Sinus + Mucus™ LiquiCaps®

active ingredients*

NDC 82706-006-01

AXIM Sinus Severe + Mucus

Cough & Congestion

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 Mucus

AXIM SINUS SEVERE MUCUS 
acetaminophen, guaifenesin, phenylephine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize22mm
FlavorImprint Code axim
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82706-006-012 in 1 CARTON05/09/2022
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:82706-006-023 in 1 CARTON09/20/202309/20/2023
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/09/2022
Labeler - VIVUNT PHARMA LLC (045829437)

Revised: 6/2024
Document Id: 1adf9d39-0e83-e929-e063-6394a90a84a5
Set id: de9eb2d5-ba54-4637-e053-2995a90a0451
Version: 12
Effective Time: 20240614
 
VIVUNT PHARMA LLC