VICKS

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-10-06 02:03:37

Label at a glance#

ProductVicks Sinex Severe All in One Sinus Mucus
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, GUAIFENESIN
Label structure19 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

Expectorant

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • 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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

  • you get nervous, dizzy or sleepless
  • 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
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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.

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
  • do not exceed 8 LiquiCaps per 24 hrs
 adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs 
 children 4 to under 12 yrsask a doctor
 children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT:This package is safely sealed & child resistant.

Use only if blisters are intact. If difficult to open, use scissors.

SPL UNCLASSIFIED SECTION

Made in Canada

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 LiquiCap Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS® Sinex™ SEVERE ALL IN ONE SINUS + MUCUS

Acetaminophen- Pain reliever/Fever Reducer,

Phenylephrine HCl - Nasal Decongestant,

Guaifenesin - Expectorant

  • Sinus Pressure
  • Sinus Headache & Pain
  • Sinus Congestion
  • Thins & Loosens Mucus

NON-DROWSY

24 LiquiCaps™

951951

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21341779951.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-95137000-951-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-11-12full-release2026-06-01 01:43:38
102025-08-06full-release2026-06-01 01:09:30

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks Sinex Severe All in One Sinus MucusACETAMINOPHEN, PHENYLEPHRINE HCL, GUAIFENESINThe Procter & Gamble Manufacturing Company9a106291-edda-2135-e053-2995a90a44fd2025-11-12WarningsExact identifier
ndc (package): 37000-951-24
ndc (product): 37000-951
ndc11 (package): 37000095124
spl set id: 9a106291-edda-2135-e053-2995a90a44fd

Reported adverse events (FAERS/openFDA)#

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