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

AXIM Sinus Severe Mucus by

Drug Labeling and Warnings

AXIM Sinus 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 4 to under 12 years: consult a doctor
• children under 4 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 carton is open or blister unit is broken.

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 24

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®

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®

INGREDIENTS AND APPEARANCE

AXIM SINUS SEVERE MUCUS 
acetaminophen, guaifenesin, phenylephine hcl 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	2 in 1 CARTON	05/09/2022
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 82706-006-02	3 in 1 CARTON	09/20/2023
2		2 in 1 POUCH; 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)