FDA.reportPublic FDA data

DayQuil Cold & Flu, Vapo Cool Coated

Manufacturer
JC World Bell Wholesale Co., Inc.
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-06 06:10:35

Label at a glance#

ProductDayQuil Cold and Flu Vapo Cool Coated
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

• 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

Acetaminophen 325 mg 
Dextromethorphan HBr 10 mg 

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation

 • sore throat • headache • minor aches & pains • fever 

WarningsLiver warning:

WARNINGS 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: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) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN 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 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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label2Outer Label2Inner Label2Inner Label2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50269-55850269-558-01
84126-352

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
571efea0-03f4-0332-e063-6394a90a719a9292be2f-0fe7-4895-9725-fd43d43cdafd2026-07-21WarningsExact identifier
spl id: 571efea0-03f4-0332-e063-6394a90a719a
spl set id: 9292be2f-0fe7-4895-9725-fd43d43cdafd

Reported adverse events (FAERS/openFDA)#

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