MedPath

Vicks DayQuil

VICKS DayQuil COLD & FLU LiquiCaps

Approved
Approval ID

efb982d4-93d0-815f-e053-2995a90a82dd

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69423-994
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (18)

SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/22/2025

PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton

VICKS ®

DayQuil

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr

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

Non-Drowsy

48 LiquiCaps™

994

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2023

Uses

temporarily relieves common cold/flu symptoms:

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/20/2023

Made in Canada

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2023

Active ingredients (in each LiquiCap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2023

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2023

Warnings

Liver warning:

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

  • more than 8 LiquiCaps in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/19/2014

Do not use

  • 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.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/20/2023

Ask a doctor before use if you have

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 9/19/2014

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/19/2014

When using this product,

do not use more than directed.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/20/2023

Stop use and ask a doctor if

  • 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

LOINC: 53414-9Updated: 8/20/2023

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/20/2023

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 8/20/2023

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2023

Directions

  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs

adults & children 12 yrs & over

2 LiquiCaps with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/20/2023

Other information

  • store at no greater than 25° C

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/22/2025

Inactive ingredients

ascorbic acid, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2023

Questions?

1-800-362-1863

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Vicks DayQuil - FDA Drug Approval Details