FDA.reportPublic FDA data

Sinus Head Congestion

Manufacturer
VIVUNT PHARMA LLC | SOFTECH PHARMA PRIVATE LIMITED
Effective date
2025-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:54

Label at a glance#

ProductSinus Head Congestion
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections

Indications and 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 and administration

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

Storage and handling

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 .

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain Reliever-Fever reducer
Phenylephrine HCl 5 mgNasal Descongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Taking the blood thinning drug warfarin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • hight blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning:

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • take only as directed (see overdose warning)
  • do not exceed 8 softgels per 24 hrs
adults and children 12 years and over2 softgels with water every 4 hours
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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

HEAD CNGESTIONHEAD CNGESTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052670acetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1052670acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1052670APAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-025-01Sinus Head Congestion8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED81
82706-025-01Sinus Head Congestion3 in 1 CARTONCAPSULE, LIQUID FILLED31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-025SINUS HEAD CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC]1Current NDC, 2 package rows20250328_30a07773-bd6f-b9f2-e063-6394a90ab8aa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-02582706-025-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PROPYLPARABENZ8IX2SC1OHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHYLPARABENA2I8C7HI9TIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
GELATIN2G86QN327LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
ndc (package): 82706-025-01
ndc (product): 82706-025
ndc11 (package): 82706002501
spl id: 30a07773-bd70-b9f2-e063-6394a90ab8aa
spl set id: 30a07773-bd6f-b9f2-e063-6394a90ab8aa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.