Vicks DayQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 23:46:36

Label at a glance#

ProductVicks DayQuil Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 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 to rid the bronchial passageways of bothersom...

Dosage and administration

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

Storage and handling

each caplet contains: sodium 4 mg store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal 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 to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or 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)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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.

Overdose warning

OVERDOSAGE SECTION

Taking more than directed can cause serious health problems. 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 4 doses per 24 hrs

adults & children 12 yrs & over - 2 caplets 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

  • each caplet contains: sodium 4 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C Yellow No. 6, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX

STRENGTH

VICKS ®

DayQuil ™
SEVERE

COLD & FLU


Acetaminophen,Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal/Sinus Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

Non-Drowsy

24 Caplets

811811

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D2
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
GuaifenesinACTIVE INGREDIENT495W7451VQ2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ2
AcetaminophenACTIVE MOIETY362O9ITL9D2
DextromethorphanACTIVE MOIETY7355X3ROTS2
GuaifenesinACTIVE MOIETY495W7451VQ2
phenylephrineACTIVE MOIETY1WS297W6MV2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH482
crospovidoneINACTIVE INGREDIENT68401960MK2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A82
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H2
polyvinyl alcoholINACTIVE INGREDIENT532B59J9902
povidonesINACTIVE INGREDIENTFZ989GH94E2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU42
stearic acidINACTIVE INGREDIENT4ELV7Z65AP2
talcINACTIVE INGREDIENT7SEV7J4R1U2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-81137000-811-02, 37000-811-12, 37000-811-24, 37000-811-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 374 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii candidate
17 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990CAPSULE / ORAL1.67 mgExact identifier — unii candidate
17 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSYSTEM / TOPICAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, DELAYED RELEASE / ORAL0.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HEMULSION / TOPICAL34050 mgExact identifier — unii candidate
78 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii candidate
78 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii candidate
17 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION, EXTENDED RELEASE / ORAL0.12 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SUSPENSION / OPHTHALMIC1.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
talcTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
22 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
15 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
17 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates

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
eb6775cb-e3a6-23cc-e053-2995a90a50c50f484aed-ed78-4701-b45a-2fcf8272951d2022-10-19WarningsExact identifier
spl set id: 0f484aed-ed78-4701-b45a-2fcf8272951d

Reported adverse events (FAERS/openFDA)#

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