FDA.reportPublic FDA data

DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), CVP

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:35

Label at a glance#

ProductDayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

Directions take only as directed do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Purpose

OTC - PURPOSE SECTION

​Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

WARNINGS SECTION

Warnings

Liver warning

SPL UNCLASSIFIED SECTION

​Liver warning:

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

  • more than 8 caplets 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

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

SPL UNCLASSIFIED SECTION

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

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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

Directions

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

Other information

SPL UNCLASSIFIED SECTION

Other information

  • store at no greater than 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
corn starch, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Questions?1-800-362-1683

DayQuil ™Cold & Flu w/VapoCOOL, 4ct (PE-free), Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS

DayQuil ™

COLD & FLU

Acetaminophen,

Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

Vapo Cool

COATED

4 Coated Caplets

[Lil' Drug Store ®logo]

PDP/PackagePDP/Package

DayQuil ™Cold & Flu w/VapoCOOL, 4ct (PE-free), CVP ®HEALTH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS

DayQuilTM

COLD & FLU

Acetaminophen,

Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCool

COATED

4 Coated Caplets

[CVP ®HEALTH logo]

PDP/PackagePDP/Package

DayQuil ™Cold & Flu w/VapoCOOL, 4ct (PE-free), Travel BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS

DayQuil ™

COLD & FLU

Acetaminophen,

Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCool

COATED

4 Coated Caplets

[Travel BASIX logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletPSN2
2709673acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD2
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletSY2
2709673APAP 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6204-2DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX2 in 1 POUCHTABLET, COATED22
66715-6204-2DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX2 in 1 CARTONTABLET, COATED22
66715-6804-2DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), CVP2 in 1 CARTONTABLET, COATED22
66715-6804-2DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), CVP2 in 1 POUCHTABLET, COATED22
66715-9604-2DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), Lil Drug Store2 in 1 CARTONTABLET, COATED22
66715-9604-2DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), Lil Drug Store2 in 1 POUCHTABLET, COATED22

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-620466715-6204-2
66715-960466715-9604-2
66715-680466715-6804-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT

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
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c55543-e05e-2f7c-e063-6394a90a45342025-06-20WarningsExact identifier
ndc (package): 66715-6204-2
ndc (package): 66715-9604-2
ndc (package): 66715-6804-2
ndc (product): 66715-9604
ndc (product): 66715-6804
ndc (product): 66715-6204
ndc11 (package): 66715680402
ndc11 (package): 66715620402
ndc11 (package): 66715960402
spl id: 3803c442-acc5-06e7-e063-6294a90ac5a7
spl set id: 37c55543-e05e-2f7c-e063-6394a90a4534

Reported adverse events (FAERS/openFDA)#

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