VICKS VAPOCOOL SEVERE WINTERFROST- 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

corn syrup, eucalyptol, FD&C Blue No. 1, flavors, glycerin, gum arabic, potassium sorbate, sucrose, water

Questions?

1-800-707-1709

SPL UNCLASSIFIED SECTION

Distributed by

Procter & Gamble

Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 70 drops in a bag

VALUE PACK

VICKS®

VapoCOOL™

SEVERE

MENTHOL ·ORAL ANESTHETIC

MAX STRENGTH FAST RELIEF

SOOTHES SORE THROAT

WINTERFROST

70 MEDICATED DROPS

INGREDIENTS AND APPEARANCE

VICKS VAPOCOOL  SEVERE WINTERFROST
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-597
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)
ACACIA (UNII: 5C5403N26O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTOL (UNII: RV6J6604TK)
WATER (UNII: 059QF0KO0R)

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: 37000-597-18	18 in 1 BAG	12/29/2017
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 37000-597-45	45 in 1 BAG	12/29/2017
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 37000-597-20	200 in 1 BAG	07/09/2019
3		1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 37000-597-70	70 in 1 BAG	05/12/2025
4		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	12/29/2017

Labeler - The Procter & Gamble Manufacturing Company (004238200)