Vicks ®

Vicks ®
SPL v18
SPL
SPL Set ID 6eef8a59-2f8a-1a90-e053-2a91aa0a1d52
Route
ORAL
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg) Acetaminophen (325 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Shellac Ascorbic Acid Dimethicone Sorbitan Mannitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: NS Shape: bullet Color: green 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 Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
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.

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 every day while using this product

Other Information
  • do not exceed 25ºC
Inactive Ingredients

ascorbic acid, FD&C Blue No. 1, 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.

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 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
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Active Ingredients (in Each Liquicap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Principal Display Panel 24 Liquicap Carton

MAX

STRENGTH

VICKS ®

NyQuil

SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate ,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

24 LIQUICAPS™

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • 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
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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 every day while using this product

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

ascorbic acid, FD&C Blue No. 1, 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.

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 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
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Active Ingredients (in Each Liquicap) (Active ingredients (in each LiquiCap))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Principal Display Panel 24 Liquicap Carton (PRINCIPAL DISPLAY PANEL - 24 LiquiCap Carton)

MAX

STRENGTH

VICKS ®

NyQuil

SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate ,Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

24 LIQUICAPS™

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

Advanced Ingredient Data


Raw Label Data

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