Vicks ®

Vicks ®
SPL v5
SPL
SPL Set ID 32f95ea0-3f39-914b-e063-6294a90a2c61
Route
ORAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Starch, Corn Microcrystalline Cellulose Magnesium Stearate Fd&c Yellow No. 6 Aluminum Lake Silicon Dioxide Titanium Dioxide Stearic Acid Polyvinyl Alcohol Sucralose Talc Povidone Crospovidone Polyethylene Glycol, Unspecified D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: NQV Shape: oval Color: orange Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-06

Description

VICKS DayQuil VapoCOOL COLD & FLU, Coated Caplets

Purpose

Pain reliever/Fever reducer Cough suppressant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Description

VICKS DayQuil VapoCOOL COLD & FLU, Coated Caplets

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 34088-5

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.

Section 42229-5

VICKS DayQuil VapoCOOL COLD & FLU, Coated Caplets

Section 50565-1

Keep out of reach of children.

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
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.
Questions?

1-800-362-1683

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

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
Other Information
  • store at no greater than 25°C (77ºF)
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

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.

When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may cause drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
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,

ask a health professional before use.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

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
Principal Display Panel Kit Carton

Vicks®

DayQuil™ VapoCOOL™ COLD & FLU + CONGESTION

Acetaminophen, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

NyQuil™ VapoCOOL™ COLD & FLU + CONGESTION

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

16 DAYQUIL COATED CAPLETS, 8 NYQUIL COATED CAPLETS: 24 TOTAL COATED CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

VICKS DayQuil VapoCOOL COLD & FLU, Coated Caplets

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Pain reliever/Fever reducer

Cough suppressant

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
Do Not Use (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.
Questions?

1-800-362-1683

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

Liver Warning: (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
Other Information (Other information)
  • store at no greater than 25°C (77ºF)
Inactive Ingredients (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

Sore Throat Warning: (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.

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may cause drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Ask A Doctor Before Use If You Have (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
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Vicks®

DayQuil™ VapoCOOL™ COLD & FLU + CONGESTION

Acetaminophen, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

NyQuil™ VapoCOOL™ COLD & FLU + CONGESTION

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

16 DAYQUIL COATED CAPLETS, 8 NYQUIL COATED CAPLETS: 24 TOTAL COATED CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)