FDA.reportPublic FDA data

Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM

Manufacturer
Procter & Gamble Manufactura S de RL de CV
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:33:35

Label at a glance#

ProductVicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • minor aches & pains • sore throat • fever • headache • cough due to minor throat & bronchial irritation • cough to help you sleep • nasal congestion • sinus congestion & pressure • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage

Dosage and administration

take only as directed do not exceed 6 doses per 24 hrs Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat Age Dose adults & children 12 yrs & over one packet (dose) every 4 hours children under 12 yrs do not use

Storage and handling

• each packet contains : potassium 10 mg • phenylketonurics: contains phenylalanine 64 mg per dose • do not exceed 25°C.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Vicks® DayQuil™ HOT REMEDYRAPID RELIEFMULTI-SYMPTOMCOLD & FLU + CONGESTION

Drug Facts

Active Ingredients (in each Packet) 

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen500 mg

Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

• minor aches & pains

• sore throat

• fever

• headache

• cough due to minor throat & bronchial irritation

• cough to help you sleep

• nasal congestion

• sinus congestion & pressure

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

Liver warning:

SPL UNCLASSIFIED SECTION

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

  • more than 6 doses in 24 hours, 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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

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.

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

do not exceed 6 doses per 24 hrs

Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes

If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat

AgeDose
adults & children 12 yrs & overone packet (dose) every 4 hours
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

• each packet contains: potassium 10 mg

• phenylketonurics: contains phenylalanine 64 mg per dose

• do not exceed 25°C.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Tamper Evident:Do not use if sachet is opened or torn

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 8 packet package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ACTION

Vicks® DayQuil™ HOT REMEDY

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

HONEY LEMON FLAVORED

8 POWDER PACKETS

550550

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN9
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD9
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY9
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY9
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90284422550.jpg.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-550-01Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION59
58933-550-08Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion8 in 1 PACKAGEPOWDER, FOR SOLUTION89
58933-550-08Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION59

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58933-55058933-550-01, 58933-550-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ASPARTAMEZ0H242BBR1IACT
SUCROSEC151H8M554IACT
FD&C RED NO. 40WZB9127XOAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf77226c0-b6d5-9fd0-e053-6294a90a4b572026-01-16WarningsExact identifier
ndc (package): 58933-550-08
ndc (package): 58933-550-01
ndc (product): 58933-550
ndc11 (package): 58933055008
ndc11 (package): 58933055001
spl id: 48824b85-d831-1ada-e063-6294a90a3793
spl set id: f77226c0-b6d5-9fd0-e053-6294a90a4b57
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf691734b-5cf4-6eb8-e053-2a95a90aee802026-01-16WarningsExact identifier
ndc (package): 58933-550-01
ndc11 (package): 58933055001

Reported adverse events (FAERS/openFDA)#

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