FDA.reportPublic FDA data

VICKS

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-10-07 01:03:13

Label at a glance#

ProductVicks NyQuil COLD and FLU
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN
Label structure11 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

Active ingredients (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 LiquiCaps 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
  • 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.

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 & 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

TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

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 ®

995995

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21421710995.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-995-022024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-022024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-022024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-022024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-082024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-082024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-082024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-082024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-162024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-162024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-162024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-162024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-242024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-242024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-242024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-242024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-482024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-482024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-482024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU
69423-995-482024-01-30C16284748780-11030e365-3fbc-111a-e063-dadaa90a10e2VICKS ® NyQuil ® COLD & FLU

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
69423-99569423-995-02, 69423-995-16, 69423-995-48, 69423-995-08, 69423-995-24

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
ACETAMINOPHEN362O9ITL9DACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-12-01full-release2026-06-01 01:19:01
112025-11-12monthly-update2026-06-03 17:38:06
102025-10-02full-release2026-06-01 01:15:40

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
Vicks NyQuil COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyefe4e649-7514-32dd-e053-2995a90a04922025-12-01WarningsExact identifier
ndc (package): 69423-995-16
ndc (package): 69423-995-08
ndc (package): 69423-995-48
ndc (package): 69423-995-24
ndc (package): 69423-995-02
ndc (product): 69423-995
ndc11 (package): 69423099524
ndc11 (package): 69423099502
ndc11 (package): 69423099508
ndc11 (package): 69423099548
ndc11 (package): 69423099516
spl set id: efe4e649-7514-32dd-e053-2995a90a0492

Reported adverse events (FAERS/openFDA)#

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