AXIM SINUX SEVERE MUCUS- acetaminophen, phenylephine hcl, guaifenesin capsule, liquid filled

AXIM Sinux Severe Mucus by

Drug Labeling and Warnings

AXIM Sinux Severe Mucus by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• 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:

• 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

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

• 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 under 12 years: do not use

Other information

• Store at 20° - 25 °C (68 °- 77 °F)
• Read all product information before using
• Tamper Evident: Do not use if the foil printed on the blister is torn or ripped

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

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

Compare VICKS ® Sinex ™

Severe All In One Sinus + Mucus LiquiCaps®

active ingredients*

NDC: 82706-006-01

AXIM Sinus Severe + Mucus

Cough and Congestion

• Pain Reliever
• Fever Reducer
• Expectorant
• Nassal Decongestant

NON-DROWSY

Acetaminophen, Phenylephrine HCl, Guaifenesin

24 SOFTGELS** **24 Liquid-filled Capsules

*This product is not manufactured or distributed by

The Procter &Gamble Company. Vicks® Sinex™

All in One Sinus + Mucus™ LiquiCaps™ are registered trademarks of

The Procter and Gamble Company

INGREDIENTS AND APPEARANCE

AXIM SINUX SEVERE MUCUS 
acetaminophen, phenylephine hcl, guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	axim
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-006-01	24 in 1 CARTON	05/09/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/09/2022

Labeler - VIVUNT PHARMA LLC (045829437)