FDA.reportPublic FDA data

Vicks NyQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-02-03
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
legacy-cache
Hydrated at
2026-08-01 21:38:17

Label at a glance#

ProductVicks NyQuil Cold and Flu Nighttime Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN
Label structure10 sections

Indications and uses

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

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 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each LiquiCap)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

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

Allergy Alert

WARNINGS 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

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 4 doses 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

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
  • 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

  • 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.

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

Taking more than directed can cause serious health problems. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs
adults & children 12 yrs & over2 LiquiCaps with water every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

Made in Canada
Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

NyQuil®

COLD & FLU

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

16 LiquiCaps ®

557557

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D4
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH4
Doxylamine SuccinateACTIVE INGREDIENTV9BI9B5YI24
AcetaminophenACTIVE MOIETY362O9ITL9D4
DextromethorphanACTIVE MOIETY7355X3ROTS4
DoxylamineACTIVE MOIETY95QB77JKPL4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3G4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD4
gelatinINACTIVE INGREDIENT2G86QN327L4
glycerinINACTIVE INGREDIENTPDC6A3C0OX4
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A4
povidonesINACTIVE INGREDIENTFZ989GH94E4
propylene glycolINACTIVE INGREDIENT6DC9Q167V34
sorbitolINACTIVE INGREDIENT506T60A25R4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP4
waterINACTIVE INGREDIENT059QF0KO0R4

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
37000-55737000-557-02, 37000-557-16, 37000-557-24, 37000-557-48, 37000-557-72, 37000-557-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 382 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii candidate
31 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii candidate
30 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii candidate
30 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii candidate
31 equally ranked IID candidates
gelatinGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii candidate
31 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates

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
f4481800-7fd4-38b0-e053-2a95a90a88939090d896-7d6f-4080-97de-bd08f62f613b2023-02-09WarningsExact identifier
spl set id: 9090d896-7d6f-4080-97de-bd08f62f613b

Reported adverse events (FAERS/openFDA)#

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