DayQuil Severe VapoCool

Manufacturer
JC World Bell Wholesale Co., Inc.
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:31:37

Label at a glance#

ProductDayQuil Severe VapoCool
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 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 ...

Dosage and administration

take only as directed - see Overdose warning  do not exceed 4 doses 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 when using other DayQuil or NyQuil products, carefully read each label to ensure correct dosing

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

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: 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 every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompained 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 as MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• liver desease • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product, 

OTC - WHEN USING SECTION

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 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,

PREGNANCY SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical helo or contact a Posion 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 - see Overdose warning 
  • do not exceed 4 doses 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
  • when using other DayQuil or NyQuil products, carefully read each label to ensure correct dosing

Other information

SPL UNCLASSIFIED SECTION

• each caplet contains: sodium 4 mg • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C Yellow No.6, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

New Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50269-52450269-524-22, 50269-524-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
ceb7e668-d68a-54e8-e053-2a95a90a28d92f6bd79a-e1d5-41ba-a63a-1e361f3a61832021-10-19WarningsExact identifier
spl id: ceb7e668-d68a-54e8-e053-2a95a90a28d9
spl set id: 2f6bd79a-e1d5-41ba-a63a-1e361f3a6183

Reported adverse events (FAERS/openFDA)#

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