Vicks ®

Vicks ®
SPL v18
SPL
SPL Set ID 6f013cc1-7885-5025-e053-2a91aa0afe11
Route
ORAL
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Mannitol Sorbitan Glycerin Ascorbic Acid Shellac Fd&c Red No. 40 Fd&c Blue No. 1 Gelatin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Titanium Dioxide Dimethicone Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: DS Shape: bullet Color: orange Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-10

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not use more than directed

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

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 LiquiCaps in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Other Information
  • store at no greater than 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

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.

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.

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

Principal Display Panel 24 Liquicapd Carton

MAX

STRENGTH

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

24 LIQUICAPS™

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
  • 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.
Section 42229-5 (42229-5)

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

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

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 LiquiCaps in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Other Information (Other information)
  • store at no greater than 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

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.

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.

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

Principal Display Panel 24 Liquicapd Carton (PRINCIPAL DISPLAY PANEL - 24 LiquiCapd Carton)

MAX

STRENGTH

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

24 LIQUICAPS™

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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