AXIV Sinus Severe Mucus
AXIV - Sinus Severe + Mucus
13245298-8b78-e177-e063-6294a90a6bec
HUMAN OTC DRUG LABEL
Sep 17, 2025
VIVUNT PHARMA LLC
DUNS: 045829437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Guaifenesin, Phenylephrine Hydrocloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - AXIV Sinus Severe + Mucus 50
Compare Vicks® Sinex ™
Severe All In One Sinus + Mucus™ LiquiCaps®
active ingredients*
NDC 82706-020-04
AXIV Sinus Severe + Mucus
Cough & Congestion
Pain Reliever
Fever Reducer
Expectorant
Nassal Decongestant
NON-DROWSY
Acetaminophen, Guaifenesin, Phenylephrine HCl
50 SOFTGELS****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®
INDICATIONS & USAGE SECTION
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
SPL UNCLASSIFIED SECTION
Distributed by:
VIVUNT PHARMA LLC
** 8950 SW 74th. Court. Suite 1901**
Miami, Florida, 33156-3178
Made in India
www.vivunt.live
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each softgel) |
Purpose |
Acetaminophen 325 mg |
Pain reliever-Fever reducer |
Guaifenesin 200 mg |
Expectorant |
Phenylephrine HCl 5 mg |
Nasal decongestant |
WARNINGS SECTION
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 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
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- Take only as directed (see overdose warning)
- Do not take more than 8 softgels in 24 hours
adults and children 12 years and over |
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 SECTION
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.
- Tamper Evident: Do not use if carton or pouch is open
INACTIVE INGREDIENT SECTION
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