Sinus Head Congestion ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE VIVUNT PHARMA LLC FDA Approved 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
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Purpose Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain Reliever-Fever reducer Phenylephrine HCl 5 mg Nasal Descongestant
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.
Strengths
325 mg 5 mg
Treats Conditions
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
Pill Appearance
Shape: oval Color: yellow Imprint: AXIV

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0850047780676
UNII
362O9ITL9D 04JA59TNSJ
Packaging

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 HEAD CNGESTION

Package Descriptions
  • 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 HEAD CNGESTION

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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. 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. Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin. 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 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. 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.
Purpose

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

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.

When Using

When using this product do not use more than directed

Stop Use & Ask a Doctor

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

Storage & Handling

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 .


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