vicks ®

vicks ®
SPL v11
SPL
SPL Set ID 9003df61-5d82-5c4d-e053-2995a90a8999
Route
oral
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (200 mg) acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 mg) doxylamine (6.25 mg)
Inactive Ingredients
shellac sorbitol fd&c red no. 40 fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water titanium dioxide dimethicone mannitol ascorbic acid sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: NS Shape: bullet Color: orange Color: green Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-07-04

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant

Description

DayQuil™ SEVERE Cold & Flu Drug Facts


Medication Information

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 passageways of bothersome mucus and make coughs more productive.
Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs
adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other Information
  • do not exceed 25ºC
Inactive Ingredients

ascorbic acid, FD&C Blue no. 1, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

Description

DayQuil™ SEVERE Cold & Flu Drug Facts

Questions?

1-800-362-1683

Section 42229-5

DayQuil™ SEVERE Cold & Flu

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before 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.
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 LiquiCaps 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 accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • 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
Active Ingredients (in Each Liquicap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Principal Display Panel 24 Liquicaps Convenience Pack

MAX

STRENGTH

Vicks ®DayQuil™ Severe and Vicks ®NyQuil™ Severe Cold & Flu LiquiCaps™

VICKS ®

DayQuil ™

SEVERE

COLD& FLU

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

8 DayQuil LiquiCaps

NyQuil ™

SEVERE

COLD& FLU

Acetaminophen, PhenylephrineHCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

16 DAYQUIL LIQUICAPS

8 NYQUIL LIQUICAPS

24 TOTAL LIQUICAPS


Structured Label Content

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 passageways of bothersome mucus and make coughs more productive.
Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs
adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other Information (Other information)
  • do not exceed 25ºC
Inactive Ingredients (Inactive ingredients)

ascorbic acid, FD&C Blue no. 1, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

Questions?

1-800-362-1683

Section 42229-5 (42229-5)

DayQuil™ SEVERE Cold & Flu

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before 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.
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 LiquiCaps 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: (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)
  • 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, & tranquilizers may increase drowsiness
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 get worse or last 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.

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
  • 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
Active Ingredients (in Each Liquicap) (Active ingredients (in each LiquiCap))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Principal Display Panel 24 Liquicaps Convenience Pack (PRINCIPAL DISPLAY PANEL - 24 LIQUICAPS Convenience Pack)

MAX

STRENGTH

Vicks ®DayQuil™ Severe and Vicks ®NyQuil™ Severe Cold & Flu LiquiCaps™

VICKS ®

DayQuil ™

SEVERE

COLD& FLU

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

8 DayQuil LiquiCaps

NyQuil ™

SEVERE

COLD& FLU

Acetaminophen, PhenylephrineHCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

16 DAYQUIL LIQUICAPS

8 NYQUIL LIQUICAPS

24 TOTAL LIQUICAPS


Advanced Ingredient Data


Raw Label Data

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