Vicks ®

Vicks ®
SPL v7
SPL
SPL Set ID fbd53e5f-bc03-75b4-e053-6394a90af028
Route
ORAL
Published
Effective Date 2023-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Phenylephrine (10 mg) Guaifenesin (400 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg)
Inactive Ingredients
D&c Yellow No. 10 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sorbitol Alcohol Sucralose Fd&c Blue No. 1 Sodium Chloride Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-22

Description

Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Section 42229-5

Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Warnings

Liver warning:

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

• more than 4 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
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 6 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

Other Information
  • each 30 mL contains: sodium 81 mg
  • store at no greater than 25°C and do not refrigerate
Inactive Ingredients

alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
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.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet
Principal Display Panel Convenience Pack

MAX STRENGTH

COOLING RELIEF

DAY & NIGHT PACK

VICKS ®

DAYQUIL NYQUIL

VICKS ® DayQuil™ VapoCOOL™

SEVERE COLD & FLU + CONGESTION

Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Chest Congestion, Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

Alcohol 10%

Vicks ®NyQuil™ VapoCOOL™

SEVERE COLD & FLU + CONGESTION

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion & Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

Alcohol 10%

2 BOTTLES - 1 DAYQUIL/1 NYQUIL; 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

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:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Section 42229-5 (42229-5)

Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

Liver warning:

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

• more than 4 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
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 6 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

Other Information (Other information)
  • each 30 mL contains: sodium 81 mg
  • store at no greater than 25°C and do not refrigerate
Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
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.

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet
Principal Display Panel Convenience Pack (PRINCIPAL DISPLAY PANEL - Convenience Pack)

MAX STRENGTH

COOLING RELIEF

DAY & NIGHT PACK

VICKS ®

DAYQUIL NYQUIL

VICKS ® DayQuil™ VapoCOOL™

SEVERE COLD & FLU + CONGESTION

Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Chest Congestion, Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

Alcohol 10%

Vicks ®NyQuil™ VapoCOOL™

SEVERE COLD & FLU + CONGESTION

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion & Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

Alcohol 10%

2 BOTTLES - 1 DAYQUIL/1 NYQUIL; 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

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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