FDA.reportPublic FDA data

Vicks DayQuil and Vicks NyQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:45:18

Label at a glance#

ProductVicks DayQuil Severe and Vicks NyQuil Severe Cold and Flu
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure19 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom...

Dosage and administration

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

do not exceed 25ºC

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DayQuil™ SEVERE Cold & Flu

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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 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
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking 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
  • pain, nasal congestion or cough get worse or last 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.

Overdose warning

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 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

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

NyQuil™ SEVERE Cold & Flu

Drug Facts

Active ingredients (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • 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 8 LiquiCaps in 24 hrs, 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.
  • to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabete
  • 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

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

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.

Overdose warning

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 8 LiquiCaps per 24 hours

adults & children 12 yrs & over 2 LiquiCaps with water every 6 hrs

children 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *May contain this ingredient

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Made in Canada
DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 LiquiCap Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX

STRENGTH

LIQUICAPS™

VICKS ®

DayQuil ™

SEVERE

COLD & FLU
Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

Non-Drowsy

16 DayQuil LiquiCaps

NyQuil ™

SEVERE

COLD & FLU


Acetaminophen, PhenylephrineHCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

8 NyQuil LiquiCaps: TOTAL 24 LIQUICAPS

2424

PRINCIPAL DISPLAY PANEL - 48 LiquiCap Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

LIQUICAPS™

VICKS ®

DayQuil ™

SEVERE

COLD & FLU


Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

Minor Aches & Pains, Fever
Nasal Congestion & Sinus Pressure
Cough
Chest Congestion

Non-Drowsy

32 DayQuil LiquiCaps


NyQuil ™

SEVERE

COLD & FLU


Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

Minor Aches & Pains, Fever
Nasal Congestion & Sinus Pressure
Sneezing, Runny Nose
Cough

Nighttime Relief

16 NyQuil LiquiCaps: TOTAL 48 LIQUICAPS

4848

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-51637000-516-48
37000-517
37000-518
37000-51437000-514-48

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIA5138Q19F1XIACT
SHELLAC46N107B71OIACT
GUAIFENESIN495W7451VQACTIB
DIMETHICONE92RU3N3Y1OIACT
SORBITOL506T60A25RIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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 NyQuil Severe Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company6eef8a59-2f8a-1a90-e053-2a91aa0a1d522026-07-02WarningsExact identifier
ndc (product): 37000-518
Vicks DayQuil Severe Cold and FluACETAMINOPHEN, PHENYLEPHINE HCL, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINThe Procter & Gamble Manufacturing Company6f013cc1-7885-5025-e053-2a91aa0afe112026-02-05WarningsExact identifier
ndc (product): 37000-517
0ab05226-0f33-c929-e063-6294a90ad95a6f03f4b2-5937-a0c2-e053-2a91aa0a9f812023-11-21WarningsExact identifier
spl set id: 6f03f4b2-5937-a0c2-e053-2a91aa0a9f81

Reported adverse events (FAERS/openFDA)#

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