Vicks ®

Vicks ®
SPL v3
SPL
SPL Set ID 1d5fee81-6509-0b87-e063-6394a90a3469
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Xanthan Gum Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sodium Citrate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-15

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
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.

Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 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

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product

• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product

• taken with other drugs containing acetaminophen

• adult has 3 or more alcoholic drinks every day while using this product

Other Information

• each 15 mL contains: sodium 46 mg

store at no greater than 25°C and do not refrigerate

Inactive Ingredients

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

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.

Principal Display Panel

VICKS ®

DayQuil ®

COLD & FLU

Acetaminophen -Pain Reliever/Fever Reducer

Phenylephrine HCl - Nasal Decongestant

Dextromethorphan HBr - Cough Suppressant



Non-Drowsy

Alcohol Free

4 FL OZ (118 mL)

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.
Active Ingredients (in Each 15 Ml)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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 as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
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.

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 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

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product

• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product

• taken with other drugs containing acetaminophen

• adult has 3 or more alcoholic drinks every day while using this product

Other Information (Other information)

• each 15 mL contains: sodium 46 mg

store at no greater than 25°C and do not refrigerate

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

VICKS ®

DayQuil ®

COLD & FLU

Acetaminophen -Pain Reliever/Fever Reducer

Phenylephrine HCl - Nasal Decongestant

Dextromethorphan HBr - Cough Suppressant



Non-Drowsy

Alcohol Free

4 FL OZ (118 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.
Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 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
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)