FDA.reportPublic FDA data

Vicks Sinex Severe

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2019-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:49:38

Label at a glance#

ProductVicks Sinex Severe Pressure and Pain
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 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 upper respiratory allergies minor aches and pains headache nasal congestion sinus congestion & pressure

Dosage and administration

take only as directed do not exceed 8 LiquiCaps per 24 hrs adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

do not exceed 25ºC

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

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 upper respiratory allergies
  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion & pressure

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 LiquiCaps 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:

SPL UNCLASSIFIED SECTION

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

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, 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product, 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED 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
  • do not exceed 8 LiquiCaps per 24 hrs

adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs

children 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Yellow No. 6, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution. *May contain this ingredient.

Questions?

OTC - QUESTIONS SECTION

1-800-873-8276

SPL UNCLASSIFIED SECTION

Made in Canada

DIST. BYPROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 LiquiCap Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

Sinex ™

SEVERE

PRESSURE & PAIN

Acetaminophen

Phenylephrine HCl

  • Pain & Headache
  • Sinus Pressure & Congestion

NON-DROWSY

24 LiquiCaps ™

sspplcsspplc

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-52637000-526-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
f433a2a7-09f7-69d2-e053-2a95a90ac4576f179b59-005e-8411-e053-2991aa0a4e9f2023-02-08WarningsExact identifier
spl set id: 6f179b59-005e-8411-e053-2991aa0a4e9f

Reported adverse events (FAERS/openFDA)#

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