Vicks DayQuil

Manufacturer
JC World Bell Wholesale Co., Inc. | Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:31:52

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 - see Overdose warning 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 when using other DayQuil or NyQuil ® products, carefully read each label to ensure correct dosing

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

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

adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other DayQuil or NyQuil ® products, carefully read each label to ensure correct dosing

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, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-251-3374

SPL UNCLASSIFIED SECTION

Product repackaged and distributed with permission of the manufacturer by:

JC World Bell Wholesale Company, Inc. Hacensack, NJ 07601

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW Fights More Symptoms than DayQuil Cold & Flu

VICKS®

DayQuil® SEVERE COLD & FLU Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

MAX STRENGTH Non-Drowsy

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

25 PACKETS OF 2 COATED CAPLETS

DayQuilDayQuil

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
DextromethorphanACTIVE MOIETY7355X3ROTS1
GuaifenesinACTIVE MOIETY495W7451VQ1
phenylephrineACTIVE MOIETY1WS297W6MV1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH481
crospovidoneINACTIVE INGREDIENT68401960MK1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A81
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
polyvinyl alcoholINACTIVE INGREDIENT532B59J9901
povidonesINACTIVE INGREDIENTFZ989GH94E1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
talcINACTIVE INGREDIENT7SEV7J4R1U1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

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
50269-81150269-811-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
polysorbate 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, COATED PELLETS / ORAL198 mgExact identifier — unii candidate
22 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48INJECTION / INTRAMUSCULAR1 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SUSPENSION / AURICULAR (OTIC)0.05 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HDROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
talcTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii candidate
30 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
30 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE / ORAL72 mgExact identifier — unii candidate
22 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
talcTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8FILM / SUBLINGUAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SUSPENSION / ORAL5 mgExact identifier — unii candidate
17 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
ceb8bf39-a6eb-01b1-e053-2a95a90ad6b586c0b17f-8228-4fc0-952b-1f24875e09302021-10-19WarningsExact identifier
spl id: ceb8bf39-a6eb-01b1-e053-2a95a90ad6b5
spl set id: 86c0b17f-8228-4fc0-952b-1f24875e0930

Reported adverse events (FAERS/openFDA)#

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