VICKS VAPOCOOL SEVERE SUGAR-FREE- 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 ingredient (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.

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 12 years and under: do not use

Other information

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

Inactive ingredients

acacia, acesulfame potassium, ascorbyl palmitate, beta-carotene, FD&C Blue No. 1, flavor, glycerin, hydrogenated starch hydrolysate, isomalt, maltodextrin, potassium sorbate, sucralose, 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

SUGAR FREE

VICKS ®

VapoCOOL™

SEVERE

MENTHOL - ORAL ANESTHETIC

SUGAR FREE

MAX STRENGTH - FAST RELIEF

WINTERFROST

30 MEDICATED DROPS

INGREDIENTS AND APPEARANCE

VICKS VAPOCOOL  SEVERE SUGAR-FREE
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-313
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
SUCROSE (UNII: C151H8M554)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ISOMALT (UNII: S870P55O2W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BETA CAROTENE (UNII: 01YAE03M7J)
ACACIA (UNII: 5C5403N26O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Product Characteristics
Color	white (with blue specks)	Score	no score
Shape	OVAL	Size	23mm
Flavor	MENTHOL	Imprint Code	vapor
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-313-30	30 in 1 BAG	06/28/2024
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	06/28/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)