Axiv - Sinus Severe + Mucus

Axiv - Sinus Severe + Mucus
SPL v6
SPL
SPL Set ID 13245298-8b78-e177-e063-6294a90a6bec
Route
ORAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Guaifenesin (200 mg) Acetaminophen (325 mg)
Inactive Ingredients
Propylparaben Glycerin Fd&c Red No. 40 D&c Red No. 33 Gelatin Polyethylene Glycol 400 Propylene Glycol Water Titanium Dioxide Sorbitol Methylparaben Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: red Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-08 Until 2024-03-08
Description

Drug Facts

Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 55105-1
Active Ingredients (in each softgel) Purpose

Acetaminophen 325 mg

Pain reliever-Fever reducer

Guaifenesin 200 mg

Expectorant
Phenylephrine HCl 5 mg

Nasal decongestant

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
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
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.

Overdose Warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

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

Principal Display Panel Axiv Sinus Severe + Mucus 100

Compare Vicks® Sinex ™

Severe All In One Sinus + Mucus™ LiquiCaps®

active ingredients*

NDC 82706-020-03

AXIV Sinus Severe + Mucus

Cough & Congestion

Pain Reliever

Fever Reducer

Expectorant

Nassal Decongestant

NON-DROWSY

Acetaminophen, Guaifenesin, Phenylephrine HCl

100 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 Axiv Sinus 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 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®

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)
Active Ingredients (in each softgel) Purpose

Acetaminophen 325 mg

Pain reliever-Fever reducer

Guaifenesin 200 mg

Expectorant
Phenylephrine HCl 5 mg

Nasal decongestant

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
Do Not Use (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
Liver Warning (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.

Overdose Warning (Overdose warning)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Information (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 (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

When Using This Product (When using this product)

do not exceed recommended dose

Stop Use and Ask A Doctor If (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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Principal Display Panel Axiv Sinus Severe + Mucus 100 (PRINCIPAL DISPLAY PANEL-AXIV Sinus Severe + Mucus 100)

Compare Vicks® Sinex ™

Severe All In One Sinus + Mucus™ LiquiCaps®

active ingredients*

NDC 82706-020-03

AXIV Sinus Severe + Mucus

Cough & Congestion

Pain Reliever

Fever Reducer

Expectorant

Nassal Decongestant

NON-DROWSY

Acetaminophen, Guaifenesin, Phenylephrine HCl

100 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 Axiv Sinus Severe + Mucus 24 (PRINCIPAL DISPLAY PANEL - AXIV Sinus 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 Axiv Sinus Severe + Mucus 50 (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®

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:01.418685 · Updated: 2026-03-14T23:10:11.873456