Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM

Manufacturer
The Procter & Gamble Manufacturing Company | SPECGX LLC
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:23:59

Label at a glance#

ProductVicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure35 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 REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION

Drug Facts

DayQuil™

Active Ingredient (in each Packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 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: 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: 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 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

SPL UNCLASSIFIED SECTION

Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION

Drug Facts

NyQuil™

Active Ingredient (in each Packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 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 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

• runny nose

• sneezing

Warnings

WARNINGS SECTION

Liver warning:

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:

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 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 the 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • breathing problem or chronic cough that lasts or 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
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• Do not use more than directed

• 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

• 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

• 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 - 16 packet package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

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

Nondrowsy

Vicks® NyQuil™ HOT REMEDY

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen,Diphenhydramine HCl, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

Nasal Congestion, Sinus Pressure

Nighttime Relief

HONEY LEMON FLAVORED

10 DAYQUIL POWDER PACKETS; 6 NYQUIL POWDER PACKETS; 16 TOTAL POWDER PACKETS

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-77769423-777-16
69423-77669423-776-01
69423-77569423-775-01

Ingredients#

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

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

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b76ccb6-83c2-ee30-e063-6394a90a414bf78330ba-b19e-3024-e053-6294a90a031a2023-12-01WarningsExact identifier
spl set id: f78330ba-b19e-3024-e053-6294a90a031a

Reported adverse events (FAERS/openFDA)#

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