FDA.reportPublic FDA data

Vicks DayQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-05-30
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:30:44

Label at a glance#

ProductVicks DayQuil Cold and Flu Multi-Symptom Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

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 46 mg • store at no greater than 25°C and do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 15 mL tablespoon)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

WARNINGS SECTION

Liver warning

WARNINGS SECTION

This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Allergy Alert

WARNINGS 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

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
  • symptoms get worse or last more than 5 days (children) or 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.

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

adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

• each 15 mL contains: sodium 46 mg
• store at no greater than 25°C and do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

Questions? 1-800-362-1683

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

DayQuil ®

COLD & FLU

Multi-Symptom Relief

Acetaminophen, Phenylephrine, Dextromethorphan

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal Congestion
  • Cough

Alcohol Free

Non-Drowsy

12 FL OZ (354 ml)

555555

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-555-082021-02-11C16284748780-1ba0f9c33-1d6c-a910-e053-dadaa90a0b85VICKS ® DayQuil ® COLD & FLU
37000-555-122021-02-11C16284748780-1ba0f9c33-1d6c-a910-e053-dadaa90a0b85VICKS ® DayQuil ® COLD & FLU
37000-555-082021-01-29C16284748780-1ba0f9c33-1d6c-a910-e053-dadaa90a0b85VICKS ® DayQuil ® COLD & FLU
37000-555-122021-01-29C16284748780-1ba0f9c33-1d6c-a910-e053-dadaa90a0b85VICKS ® DayQuil ® COLD & FLU

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-555-08ML - Milliliter37000-555462a3b78-f299-4cd6-9e74-23ba06f2bfeb12013-06-04
37000-555-12ML - Milliliter37000-55549e35302-3e25-4b02-a6e2-a47828127d8c12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D4
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH4
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ4
AcetaminophenACTIVE MOIETY362O9ITL9D4
DextromethorphanACTIVE MOIETY7355X3ROTS4
phenylephrineACTIVE MOIETY1WS297W6MV4
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS3114
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP4
edetate disodiumINACTIVE INGREDIENT7FLD91C86K4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A84
glycerinINACTIVE INGREDIENTPDC6A3C0OX4
propylene glycolINACTIVE INGREDIENT6DC9Q167V34
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY4
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU4
sodium chlorideINACTIVE INGREDIENT451W47IQ8X4
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR4
sorbitolINACTIVE INGREDIENT506T60A25R4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD44
waterINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-55537000-555-08, 37000-555-12, 37000-555-04, 37000-555-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 12 · 668 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
44 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XGEL / VAGINAL10 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 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
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, EMULSION / INTRAVENOUS0.62 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRATYMPANIC2 mgExact identifier — unii candidate
134 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, EXTENDED RELEASE / ORAL933 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 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
09aa7fde-fad7-89cf-e063-6294a90a07f0cd71be9f-4013-4ecd-9fcd-2bd3ffb7cf082023-11-08WarningsExact identifier
spl set id: cd71be9f-4013-4ecd-9fcd-2bd3ffb7cf08

Reported adverse events (FAERS/openFDA)#

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