DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

Drug Labeling and Warnings

Drug Details

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COOL RELIEF ORAL ANESTHETIC- menthol lozenge 
Ricola USA Inc.

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.

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DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

Drug Facts

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

Menthol, 8.3 mg

Uses

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings

Sore throat warnings:

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.

Keep out of reach of children.


Directions

  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

protect from heat and moisture

Inactive Ingredients

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

Image of Cool Relief MFP08S-86.jpg

COOL RELIEF ORAL ANESTHETIC 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63667-153
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15.3 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize24mm
FlavorMENTHOL (Icy Menthol) Imprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63667-153-1919 in 1 BAG; Type 0: Not a Combination Product06/01/2018
2NDC: 63667-153-2424 in 1 BAG; Type 0: Not a Combination Product06/01/2018
3NDC: 63667-153-4545 in 1 BAG; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2018
Labeler - Ricola USA Inc. (177265261)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag 485393768manufacture(63667-153)

Revised: 6/2018
 
Ricola USA Inc.


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