Vicks @

Vicks @
SPL v1
SPL
SPL Set ID 42b74523-1389-c7ff-e063-6394a90a2f5f
Route
ORAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Trisodium Citrate Dihydrate D&c Yellow No. 10 Tricalcium Phosphate Sucrose Aspartame Fd&c Blue No. 1 Fd&c Red No. 40 Carboxymethylcellulose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11
Description

Vicks® DayQuil™ HOT REMEDY COLD & FLU Drug Facts DayQuil™

Purpose

Headache, Fever, Sore Throat, Minor Aches & Pains Cough

Medication Information

Purpose

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Description

Vicks® DayQuil™ HOT REMEDY COLD & FLU Drug Facts DayQuil™

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 42229-5

Vicks® DayQuil™ HOT REMEDY COLD & FLU

Drug Facts

DayQuil™

Section 50565-1

Keep out of reach of children.

Directions
  • take only as directed
  • do not exceed 6 doses per 24 hrs
  • Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
  • If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat
Age Dose
adults & children 12 yrs & over one packet (dose) every 4 hours
children under 12 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 6 doses 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
Liver Warning: 

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

  • more than 6 doses 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
  • each packet contains: potassium 10 mg
  • phenylketonurics: contains phenylalanine 68 mg per dose
  • store at no greater than 25°C (77°F)
Inactive Ingredients

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate

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.

Inactive Ingredients:

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate

When Using This Product
  • excitability may occur especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase 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,

Keep Out of Reach of Children.

Active Ingredient (in Each Packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 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, or emphysema
Principal Display Panel 6 Packet Package

NEW FORMULAS

VALUE PACK

Vicks ®DayQuil™ HOT REMEDY

COLD & FLU

Acetaminophen,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Non-Drowsy

Vicks ®NyQuil™ HOT REMEDY

COLD & FLU

Acetaminophen, Diphenhydramine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough, Sneezing, Runny Nose

Nighttime Relief

HONEY LEMON FLAVORED

3 DAYQUIL PACKETS; 3 NYQUIL PACKETS; 6 TOTAL PACKETS

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 42229-5 (42229-5)

Vicks® DayQuil™ HOT REMEDY COLD & FLU

Drug Facts

DayQuil™

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Directions
  • take only as directed
  • do not exceed 6 doses per 24 hrs
  • Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
  • If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat
Age Dose
adults & children 12 yrs & over one packet (dose) every 4 hours
children under 12 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 6 doses 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
Liver Warning:  (Liver warning: )

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

  • more than 6 doses 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)
  • each packet contains: potassium 10 mg
  • phenylketonurics: contains phenylalanine 68 mg per dose
  • store at no greater than 25°C (77°F)
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate

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.

Inactive Ingredients: (Inactive ingredients:)

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate

When Using This Product (When using this product)
  • excitability may occur especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase 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,)

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredient (in Each Packet) (Active Ingredient (in each Packet))

Acetaminophen 500 mg

Dextromethorphan HBr 20 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, or emphysema
Principal Display Panel 6 Packet Package (PRINCIPAL DISPLAY PANEL - 6 packet package)

NEW FORMULAS

VALUE PACK

Vicks ®DayQuil™ HOT REMEDY

COLD & FLU

Acetaminophen,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough

Non-Drowsy

Vicks ®NyQuil™ HOT REMEDY

COLD & FLU

Acetaminophen, Diphenhydramine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Cough, Sneezing, Runny Nose

Nighttime Relief

HONEY LEMON FLAVORED

3 DAYQUIL PACKETS; 3 NYQUIL PACKETS; 6 TOTAL PACKETS

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:54.866255 · Updated: 2026-03-14T23:13:23.763125