Vicks ®

Vicks ®
SPL v4
SPL
SPL Set ID 1b579102-9eac-1b2f-e063-6394a90add0a
Route
ORAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Sucralose Xanthan Gum Sorbitol Fd&c Green No. 3 D&c Yellow No. 10 Citric Acid Monohydrate Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-07

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

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

Questions?

1-800-362-1683

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

Other Information
  • each 15 mL contains: sodium 14 mg
  • Store at no greater than 25 C and do not refrigerate.
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

Inactive Ingredients

citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, 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.

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) 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.[Text Wrapping Break]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)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 354 Ml Bottle Label

VICKS ®DayQuil™ SEVERE

HONEY COLD & FLU

Acetaminophen,Guaifensin, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Chest Congestion, Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

12 FL OZ (354 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
  • 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

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

Questions?

1-800-362-1683

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

Other Information (Other information)
  • each 15 mL contains: sodium 14 mg
  • Store at no greater than 25 C and do not refrigerate.
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

Inactive Ingredients (Inactive ingredients)

citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, 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.

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) 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.[Text Wrapping Break]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)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label)

VICKS ®DayQuil™ SEVERE

HONEY COLD & FLU

Acetaminophen,Guaifensin, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Chest Congestion, Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

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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