Vicks ®

Vicks ®
SPL v8
SPL
SPL Set ID 911a05de-cb3f-c1d2-e053-2995a90ae4be
Route
ORAL
Published
Effective Date 2023-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg) Menthol (20 mg)
Inactive Ingredients
Sucrose Corn Syrup Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: Vicks;logo Shape: round Color: yellow Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-09

Description

Drug Facts

Purpose

Oral anesthetic Oral anesthetic


Medication Information

Purpose

Oral anesthetic

Oral anesthetic

Description

Drug Facts

Uses

temporarily relieves occasional minor irritation and pain due to

  • sore throat
  • sore mouth
Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Directions
  • adults and children 12 years and over: dissolve 1 lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
  • children under 12 years: do not use.
Do Not Use
  • for teething
  • in children under 2
Questions?

1-800-283-4879

Allergy Alert:

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

Other Information
  • store at room temperature; protect from moisture
  • contains soy
Inactive Ingredients

corn syrup, flavors, propylene glycol, sucrose

Sore Throat Warning –

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

When Using This Product

do not exceed recommended dosage

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy
Stop Use and Ask A Doctor If
  • sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens
Active Ingredients (per Lozenge)

Benzocaine 15 mg

Menthol 20 mg

Ask A Doctor Before Use If You Have
  • a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Principal Display Panel 16 Lozenges Carton

VICKS ®

VapoCOOL

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

COOLING + NUMBING

Soothes Throat Pain

Fast-acting

WINTERFROST

16 LOZENGES


Structured Label Content

Uses

temporarily relieves occasional minor irritation and pain due to

  • sore throat
  • sore mouth
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Purpose

Oral anesthetic

Oral anesthetic

Directions
  • adults and children 12 years and over: dissolve 1 lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
  • children under 12 years: do not use.
Do Not Use (Do not use)
  • for teething
  • in children under 2
Questions?

1-800-283-4879

Allergy Alert: (Allergy alert:)

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

Other Information (Other information)
  • store at room temperature; protect from moisture
  • contains soy
Inactive Ingredients (Inactive ingredients)

corn syrup, flavors, propylene glycol, sucrose

Sore Throat Warning –

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

When Using This Product (When using this product)

do not exceed recommended dosage

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens
Active Ingredients (per Lozenge) (Active ingredients (per lozenge))

Benzocaine 15 mg

Menthol 20 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Principal Display Panel 16 Lozenges Carton (PRINCIPAL DISPLAY PANEL - 16 Lozenges Carton)

VICKS ®

VapoCOOL

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

COOLING + NUMBING

Soothes Throat Pain

Fast-acting

WINTERFROST

16 LOZENGES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)