vicks ®

vicks ®
SPL v16
SPL
SPL Set ID 5bbe271e-0344-4926-991c-3115756b908e
Route
oral
Published
Effective Date 2026-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) guaifenesin (200 mg) phenylephrine (5 mg)
Inactive Ingredients
citric acid monohydrate fd&c yellow no. 6 glycerin propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph drug active Since 2013-07-22

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Drug Facts


Medication Information

Warnings

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

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.

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
  • 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

Other Information
  • each 15 mL contains:sodium 47 mg
  • store at no greater than 25ºC 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

Description

Drug Facts

Questions?

1-800-362-1683

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Do Not Use

• with any 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.

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 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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet
Principal Display Panel 354 Ml Bottle Label

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



Alcohol Free

12 FL OZ (354 ml)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Warnings

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

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.

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
  • 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

Other Information (Other information)
  • each 15 mL contains:sodium 47 mg
  • store at no greater than 25ºC 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

Questions?

1-800-362-1683

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Do Not Use (Do not use)

• with any 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.

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 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet
Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label)

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



Alcohol Free

12 FL OZ (354 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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