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

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.

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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

PRINCIPAL DISPLAY PANEL - AXIM Sinux Severe + Mucus 6

Compare Vicks® Sinex ™

Severe All In One Sinus + Mucus™ LiquiCaps®

active ingredients*

NDC 82706-006-02

AXIM Sinus Severe + Mucus

Cough & Congestion

Pain Reliever
Fever Reducer
Expectorant
Nassal Decongestant

NON-DROWSY

Acetaminophen, Guaifenesin, Phenylephrine HCl

6 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

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
POVIDONE K30 (UNII: U725QWY32X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
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 CARTON09/20/2023
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
Labeler - VIVUNT PHARMA LLC (045829437)

Revised: 9/2023
Document Id: 05d329c8-d2a4-da24-e063-6294a90a91d5
Set id: de9eb2d5-ba54-4637-e053-2995a90a0451
Version: 11
Effective Time: 20230920
 
VIVUNT PHARMA LLC