VICKS VAPOCOOL HYDRASOOTHE- menthol lozenge 
The Procter & Gamble Manufacturing Company

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™
HydraSoothe
Medicated Drops

Drug Facts

Active ingredient (per drop)

Menthol 15 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.

Inactive ingredients

eucalyptol, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, gum arabic, potassium sorbate, sucrose, water

Questions?

1-800-707-1709

Distributed by
Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 50 Drop Bag

VICKS®

VapoCOOL™

HYDRASOOTHE

MENTHOL ·ORAL ANESTHETIC

WINTERFROST

  • Powerful Rush of Vicks Vapors
  • Soothes Sore Throats
  • Hydrating Action*

ACTUAL SIZE

50 MEDICATED DROPS

936

VICKS VAPOCOOL  HYDRASOOTHE
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-936
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
ACACIA (UNII: 5C5403N26O)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
EUCALYPTOL (UNII: RV6J6604TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue (with blue specks) Scoreno score
ShapeOVALSize23mm
FlavorMENTHOLImprint Code VICKS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-936-5050 in 1 BAG07/09/201907/09/2019
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/09/201907/09/2019
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2023
Document Id: 051d2804-b052-7e2c-e063-6394a90a22b3
Set id: 911afffc-4ec5-7de7-e053-2995a90aea3f
Version: 4
Effective Time: 20230911
 
The Procter & Gamble Manufacturing Company