FDA.reportPublic FDA data

Vicks DayQuil NyQuil HOT REMEDY

Manufacturer
Procter & Gamble Manufactura S de RL de CV
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:56

Label at a glance#

ProductVicks DayQuil NyQuil HOT REMEDY Cold and Flu
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure39 sections

Indications and uses

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

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 68 mg per dose store at no greater than 25°C (77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Vicks® DayQuil™ HOT REMEDY COLD & FLU

Drug Facts

DayQuil™

Active Ingredient (in each Packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Purpose

OTC - PURPOSE SECTION

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

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

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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain 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.

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 68 mg per dose
  • store at no greater than 25°C (77°F)

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, flavor, sodium citrate, sucrose, tricalcium phosphate

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

SPL UNCLASSIFIED SECTION

Vicks® NyQuil™ HOT REMEDY COLD & FLU

Drug Facts

NyQuil™

Active Ingredient (in each Packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/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 sore throat & bronchial irritation
  • cough to help you sleep
  • runny nose
  • sneezing

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.
  • with any other product containing diphenhydramine, even one used on skin.
  • 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • excitability may occur especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 yrs do not use

Other information

STORAGE AND HANDLING SECTION

• each packet contains:potassium 10 mg

  • phenylketonurics: contains phenylalanine 68 mg per dose
  • store at no greater than 25°C (77°F)

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, flavor, sodium citrate, sucrose, tricalcium phosphate

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SACHET IS OPENED OR TORN

Keep outer package for complete product information.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 6 packet package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULAS

VALUE PACK

Vicks ®DayQuil™ HOT REMEDY

COLD & FLU

Acetaminophen,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Non-Drowsy

Vicks ®NyQuil™ HOT REMEDY

COLD & FLU

Acetaminophen, Diphenhydramine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough, Sneezing, Runny Nose

Nighttime Relief

HONEY LEMON FLAVORED

3 DAYQUIL PACKETS; 3 NYQUIL PACKETS; 6 TOTAL PACKETS

554554

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2679426{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } PackGPCK1
26794261 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) PackPSN1
2679420acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionPSN1
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionPSN1
2679425acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral SolutionPSN1
2679420acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionSCD1
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSCD1
2679425acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral SolutionSCD1
2679426{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } PackSY1
26794261 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) PackSY1
2679420APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionSY1
2670598APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSY1
2679425APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21247050554.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-552-01Vicks DayQuil NyQuil HOT REMEDYCold and Flu5 g in 1 PACKETPOWDER, FOR SOLUTION5 g500 mg in 5g1
58933-553-01Vicks DayQuil NyQuil HOT REMEDYCold and Flu5 g in 1 PACKETPOWDER, FOR SOLUTION5 g650 mg in 5g1
58933-554-06Vicks DayQuil NyQuil HOT REMEDYCold and Flu1 in 1 PACKAGEKIT11
58933-554-16Vicks DayQuil NyQuil HOT REMEDYCold and Flu1 in 1 PACKAGEKIT11

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
58933-55458933-554-16, 58933-554-06
58933-55358933-553-01
58933-55258933-552-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
SUCROSEC151H8M554IACT
ASPARTAMEZ0H242BBR1IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ACETAMINOPHEN362O9ITL9DACTIB
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCROSEC151H8M554IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
FD&C RED NO. 40WZB9127XOAIACT
ASPARTAMEZ0H242BBR1IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5afa0840-c51f-0489-e063-6394a90ac4ae42b74523-1389-c7ff-e063-6394a90a2f5f2026-09-08WarningsExact identifier
spl set id: 42b74523-1389-c7ff-e063-6394a90a2f5f

Reported adverse events (FAERS/openFDA)#

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