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Vicks VapoCOOL Severe

Dosage form: lozenge
Ingredients: MENTHOL 20mg
Labeler: The Procter & Gamble Manufacturing Company
NDC Code: 37000-894

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Vicks ® VapoCOOL
Severe

Drug Facts

Active ingredient (per drop)

Menthol 20 mg

Purpose

Oral anesthetic

Uses

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 5 years of age unless directed by doctor.

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. 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 20°-25°C (68°-77°F) in a dry place
  • Contains Soy. May contain Peanuts, Milk,Wheat, Nuts or Tree Nuts

Inactive ingredients

Corn Syrup, Eucalyptol, FD&C Blue No. 1, Flavors, Glycerin, Gum Arabic, Potassium Sorbate, Sucrose,Water

Questions?

1-800-707-1709

DISTRIBUTED BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 20 Drop Bag

VICKS®

VapoCOOL

SEVERE

MENTHOL ·ORAL ANESTHETIC

WINTERFROST

Max Strength

Powerful Rush of Vicks Vapors
Soothes Sore Throats

18 Drops

VICKS VAPOCOOL  SEVERE
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-894
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL20 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
ACACIA 
POTASSIUM SORBATE 
GLYCERIN 
FD&C BLUE NO. 1 
CORN SYRUP 
EUCALYPTOL 
WATER 
Product Characteristics
Colorwhite (with blue specks) Scoreno score
ShapeOVALSize23mm
FlavorMENTHOLImprint CodeVICKS
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-894-1818 POUCH in 1 BAG
11 LOZENGE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/29/2017
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 01/2018
 
The Procter & Gamble Manufacturing Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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