Other
Drug Facts
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida, 33156-3178
Made in India
www.vivunt.live
Axiv Sinus Severe Mucus Capsule, Liquid Filled
FDA Label NDC 82706-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv Sinus Severe Mucus (NDC 82706-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 Softgels in 24 hours, which is the maximum daily amount for this product.
- 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.
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 |
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 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
Principal Display Panel - Axim Sinux Severe + Mucus 24
Compare Vicks® Sinex ™
Severe All In One Sinus + Mucus™ LiquiCaps®
active ingredients*
NDC 82706-020-01
AXIV Sinus Severe + Mucus
Cough & Congestion
Pain Reliever
Fever Reducer
Expectorant
Nassal Decongestant
NON-DROWSY
Acetaminophen, Guaifenesin, Phenylephrine HCl
24 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®
Principal Display Panel - Axim Sinux Severe + Mucus 4
Compare Vicks® Sinex ™
Severe All In One Sinus + Mucus™ LiquiCaps®
active ingredients*
NDC 82706-020-02
AXIV Sinus Severe + Mucus
Cough & Congestion
Pain Reliever
Fever Reducer
Expectorant
Nassal Decongestant
NON-DROWSY
Acetaminophen, Guaifenesin, Phenylephrine HCl
4 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®
* Please review the disclaimer below.
