Vicks ®

Vicks ®
SPL v12
SPL
SPL Set ID f691734b-5cf4-6eb8-e053-2a95a90aee80
Route
ORAL
Published
Effective Date 2023-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Phenylephrine (10 mg) Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Acesulfame Potassium Citric Acid Monohydrate Carboxymethylcellulose D&c Yellow No. 10 Sucrose Aspartame Fd&c Red No. 40 Tribasic Calcium Phosphate Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-20 Until 2027-06-30

Description

Vicks® DayQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION Drug Facts DayQuil™

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Vicks® DayQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION Drug Facts DayQuil™

Uses

temporarily relieves common cold/flu symptoms:

• minor aches & pains

• sore throat

• fever

• headache

• cough due to minor throat & bronchial irritation

• cough to help you sleep

• nasal congestion

• sinus congestion & pressure

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Section 42229-5

Vicks® DayQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION

Drug Facts

DayQuil™

Warnings

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

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.

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

Other Information

• each packet contains: potassium 10 mg

• phenylketonurics: contains phenylalanine 64 mg per dose

• do not exceed 25°C.

Inactive Ingredients

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

Inactive Ingredients:

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

When Using This Product

• Do not use more than directed

• 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

When Using This Product, 

do not use more than directed

Stop Use and Ask A Doctor If

• 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,

ask a health professional before use.

Keep Out of Reach of Children.

Active Ingredient (in Each Packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • trouble urinating due to enlarged prostate gland
Principal Display Panel 16 Packet Package

MAX STRENGTH

Vicks® DayQuil™ HOT REMEDY

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen,Dextromethorphan HBr, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

Vicks® NyQuil™ HOT REMEDY

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

Nasal Congestion, Sinus Pressure

Nighttime Relief

HONEY LEMON FLAVORED

10 DAYQUIL POWDER PACKETS; 6 NYQUIL POWDER PACKETS; 16 TOTAL POWDER 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:

• minor aches & pains

• sore throat

• fever

• headache

• cough due to minor throat & bronchial irritation

• cough to help you sleep

• nasal congestion

• sinus congestion & pressure

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Section 42229-5 (42229-5)

Vicks® DayQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION

Drug Facts

DayQuil™

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

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.

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

Other Information (Other information)

• each packet contains: potassium 10 mg

• phenylketonurics: contains phenylalanine 64 mg per dose

• do not exceed 25°C.

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, flavors, sucrose, tribasic calcium phosphate

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, flavors, sucrose, tribasic calcium phosphate

When Using This Product (When using this product)

• Do not use more than directed

• 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

When Using This Product,  (When using this product, )

do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• 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, (If pregnant or breast-feeding,)

ask a health professional before use.

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

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • trouble urinating due to enlarged prostate gland
Principal Display Panel 16 Packet Package (PRINCIPAL DISPLAY PANEL - 16 packet package)

MAX STRENGTH

Vicks® DayQuil™ HOT REMEDY

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen,Dextromethorphan HBr, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

Vicks® NyQuil™ HOT REMEDY

RAPID RELIEF

MULTI-SYMPTOM

COLD & FLU + CONGESTION

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

Nasal Congestion, Sinus Pressure

Nighttime Relief

HONEY LEMON FLAVORED

10 DAYQUIL POWDER PACKETS; 6 NYQUIL POWDER PACKETS; 16 TOTAL POWDER 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

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