VICKS VAPOCOOL SEVERE PLUS INTENSE PAIN RELIEF- benzocaine and menthol lozenge

Vicks VapoCool by

Drug Labeling and Warnings

Vicks VapoCool by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (per drop)

Benzocaine 15 mg
Menthol 20 mg

Purpose

Oral anesthetic

Oral anesthetic

Uses

temporarily relieves occasional minor irritation and pain due to

• sore throat
• sore mouth

Warnings

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

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.

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.

Do not use

• for teething
• in children under 2

When using this product

do not exceed recommended dosage

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

Directions

• adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
• children under 12 years: do not use.

Other information

• Store at no greater than 25°C (77°F)
• contains soy

Inactive ingredients

acacia, ascorbyl palmiltate, beta-carotene, corn syrup, FD&C Blue No. 1, flavor, maltodextrin, propylene glycol, sucrose, sunflower oil, vitamin E DL-alpha, water

Questions?

1-800-707-1709

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DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 30 MEDICATED DROPS

VICKS ®

VapoCOOL

SEVERE

MENTHOL & BENZOCAINE - ORAL ANESTHETICS

+INTENSE PAIN RELIEF

SOOTHES & NUMBS

SORE THROATS

ICY MINT

30 MEDICATED DROPS

INGREDIENTS AND APPEARANCE

VICKS VAPOCOOL  SEVERE PLUS INTENSE PAIN RELIEF
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-366
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETA CAROTENE (UNII: 01YAE03M7J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
WATER (UNII: 059QF0KO0R)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	23mm
Flavor	MINT	Imprint Code	Vicks;Vapors
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-366-30	30 in 1 BAG	07/15/2025
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/15/2025

Labeler - The Procter & Gamble Manufacturing Company (004238200)