SINUS HEAD CONGESTION- acetaminophen, phenylephrine hydrochloride capsule, liquid filled

Sinus Head Congestion by

Drug Labeling and Warnings

Sinus Head Congestion by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC, SOFTECH PHARMA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Purpose

• 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

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.

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

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.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SINUS HEAD CONGESTION 
acetaminophen, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-025
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AXIV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-025-01	3 in 1 CARTON	03/18/2025
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/18/2025

Labeler - VIVUNT PHARMA LLC (045829437)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTECH PHARMA PRIVATE LIMITED		677111277	manufacture(82706-025)