VICKS VAPOCOOL SEVERE- 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (per drop)

Menthol 20 mg

Purpose

Oral anesthetic

Uses

temporarily relieves occasional minor irritation and pain due to

• sore throat
• sore mouth

Warnings

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.

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.

SPL UNCLASSIFIED SECTION

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 20°-25°C (68°-77°F) in a dry place
• contains soy

Inactive ingredients

beta carotene, corn syrup, flavors, honey, sucrose, water

Questions?

1-800-707-1709

SPL UNCLASSIFIED SECTION

DIST. BY:

PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 45 drops in a bag

STARTS WORKING IN SECONDS!

VICKS®

VapoCOOL ™

SEVERE

MENTHOL ORAL ANESTHETIC

MAX STRENGTH FAST RELIEF

SOOTHES SORE THROAT

HONEY LEMON CHILL

45 MEDICATED DROPS

INGREDIENTS AND APPEARANCE

VICKS VAPOCOOL  SEVERE
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-797
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)
CORN SYRUP (UNII: 9G5L16BK6N)
SUCROSE (UNII: C151H8M554)
BETA CAROTENE (UNII: 01YAE03M7J)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	23mm
Flavor	HONEY (Lemon)	Imprint Code	vapor
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-797-18	18 in 1 BAG	07/03/2021
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69423-797-45	45 in 1 BAG	07/03/2021
2		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	07/03/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)