FDA.reportPublic FDA data

VICKS

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-10-07 01:02:24

Label at a glance#

ProductVicks DayQuil Cold and Flu
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

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Nasal 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

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.

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.

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 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 aretaking 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.

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

 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

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr

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

Non-Drowsy

Alcohol Free

12 FL OZ

(354 ml)

788788

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900014367GTIN-13: 0323900014367
EAN-13: 0323900014367
GTIN-12: 323900014367
UPC-A: 323900014367
GTIN storage (14 digits): 00323900014367		788.jpg
Data codeData Matrix21521487788.jpg
Data codeData Matrix91014462788.jpg

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-78869423-788-08, 69423-788-12, 69423-788-04, 69423-788-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-06-23monthly-update2026-07-17 21:35:32
72026-02-19full-release2026-06-01 01:46:45

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks DayQuil Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyfc9a43d8-0359-9def-e053-6294a90a7e912026-06-23WarningsExact identifier
ndc (package): 69423-788-04
ndc (package): 69423-788-06
ndc (package): 69423-788-12
ndc (package): 69423-788-08
ndc (product): 69423-788
ndc11 (package): 69423078808
ndc11 (package): 69423078806
ndc11 (package): 69423078804
ndc11 (package): 69423078812
spl set id: fc9a43d8-0359-9def-e053-6294a90a7e91
Vicks DayQuil and Vicks NyQuil Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company04dc3835-64be-d9e4-e063-6394a90a85992026-06-22WarningsExact identifier
ndc (package): 69423-788-12
ndc11 (package): 69423078812
Vicks DayQuil and Vicks NyQuil Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company416c6674-e4aa-6375-e054-00144ff8d46c2026-02-20WarningsExact identifier
ndc (package): 69423-788-12
ndc11 (package): 69423078812

Reported adverse events (FAERS/openFDA)#

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