Vicks Severe

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2023-05-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:31:27

Label at a glance#

ProductVicks Severe Cold and Flu
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure18 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions torid the bronchial passageways of bothersome...

Dosage and administration

take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Storage and handling

each 15 mL contains: sodium 14 mg Store at no greater than 25C and do not refrigerate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifensin 200 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions torid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks daily while using this product

Allergy Alert: 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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)
  • a breathing problem or chronic cough that lasts or 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

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

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults)
  • 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.

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 & for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 4 hrs

children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 14 mg
  • Store at no greater than 25C and do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Made in Canada

DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

DayQuil SEVERE ™

HONEY FLAVOR

COLD & FLU

Acetaminophen,

Guaifensin, Phenylephrine HCl,

Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Chest Congestion,

Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

12 FL OZ (354 ml)

970970

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-97037000-970-12, 37000-970-08

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 · Source PDF

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
051a3466-35f6-a9bf-e063-6294a90afaaaa45edc18-6724-170d-e053-2a95a90a6acf2023-09-11WarningsExact identifier
spl set id: a45edc18-6724-170d-e053-2a95a90a6acf

Reported adverse events (FAERS/openFDA)#

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