Axiv Sinus Head Congestion

Axiv Sinus Head Congestion
SPL v1
SPL
SPL Set ID 30a07773-bd6f-b9f2-e063-6394a90ab8aa
Route
ORAL
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Propylparaben Titanium Dioxide Methylparaben Povidone K30 Water Propylene Glycol Sorbitol Polyethylene Glycol 400 Gelatin Fd&c Yellow No. 6 Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: yellow Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-18

Description

Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain Reliever-Fever reducer Phenylephrine HCl 5 mg Nasal Descongestant

Purpose

Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain Reliever-Fever reducer Phenylephrine HCl 5 mg Nasal Descongestant


Medication Information

Purpose
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain Reliever-Fever reducer
Phenylephrine HCl 5 mg Nasal Descongestant

Description

Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain Reliever-Fever reducer Phenylephrine HCl 5 mg Nasal Descongestant

Uses
  • Temporarily relieves symptoms due to the common cold (or a cold)
  • minor aches and pains
  • headache
  • fever
  • nasal congestion
  • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other respiratory allergies
Section 51945-4

Compare to Vicks® Sinex TM

Severe All in One Sinus TM

Liquicaps®

active ingredients*

NDC 82706-025-01

Sinus

HEAD CONGESTION

PRESSURE & PAIN

-Sinus Pressure

-Sinus Headache & Pain

-Sinus Cingestion

-Stuffy Nose

NON-DROWSY

Acetaminophen

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 TM All in One Sinus TM LiquiCaps ®.

Lic. No. :"DD/DRUGS/DD/416"

VIVUNT TM

Distributed by: VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178. Made in India.

www.vivunt.live

Warnings

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 daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay include:

  • skin reddening
  • blisters
  • rash.
  • If a skin reaction occurs, stop use and seek medical help right away.
Directions
  • take only as directed (see overdose warning)
  • do not exceed 8 softgels per 24 hrs
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, psyciatric 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.
Other Information

Do not exceed 25°C

TAMPER EVIDENT:This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive Ingredients

FD&C yellow no.6, Gelatin, Glycerin, Methylparaben, Polyethylene glycol 400, Povidone K 30, Propylene glycol, Propyparaben, Purified water, Sorbitol, Titanium Dioxide.

When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If
  • 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
  • you get nervous, dizzy or sleepless
Keep Out of Reach of Children

Keep out of reach of children

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • hight blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • Temporarily relieves symptoms due to the common cold (or a cold)
  • minor aches and pains
  • headache
  • fever
  • nasal congestion
  • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other respiratory allergies
Section 51945-4 (51945-4)

Compare to Vicks® Sinex TM

Severe All in One Sinus TM

Liquicaps®

active ingredients*

NDC 82706-025-01

Sinus

HEAD CONGESTION

PRESSURE & PAIN

-Sinus Pressure

-Sinus Headache & Pain

-Sinus Cingestion

-Stuffy Nose

NON-DROWSY

Acetaminophen

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 TM All in One Sinus TM LiquiCaps ®.

Lic. No. :"DD/DRUGS/DD/416"

VIVUNT TM

Distributed by: VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178. Made in India.

www.vivunt.live

Purpose
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain Reliever-Fever reducer
Phenylephrine HCl 5 mg Nasal Descongestant

Warnings

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 daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay include:

  • skin reddening
  • blisters
  • rash.
  • If a skin reaction occurs, stop use and seek medical help right away.
Directions
  • take only as directed (see overdose warning)
  • do not exceed 8 softgels per 24 hrs
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, psyciatric 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.
Other Information (Other information)

Do not exceed 25°C

TAMPER EVIDENT:This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Overdose Warning: (Overdose warning:)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive Ingredients (Inactive ingredients)

FD&C yellow no.6, Gelatin, Glycerin, Methylparaben, Polyethylene glycol 400, Povidone K 30, Propylene glycol, Propyparaben, Purified water, Sorbitol, Titanium Dioxide.

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
  • you get nervous, dizzy or sleepless
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

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

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • hight blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
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.


Advanced Ingredient Data


Raw Label Data

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