COOL RELIEF ORAL ANESTHETIC- menthol lozenge

COOL RELIEF ORAL ANESTHETIC by

Drug Labeling and Warnings

COOL RELIEF ORAL ANESTHETIC by is a Otc medication manufactured, distributed, or labeled by Ricola Ag, Ricola Ag , Associated Production Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Bulk Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL RELIEF ORAL ANESTHETIC 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54305-153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15.3 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	24mm
Flavor	MENTHOL (Icy Menthol)	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54305-153-19	19 in 1 BAG; Type 0: Not a Combination Product	06/01/2018
2	NDC: 54305-153-24	24 in 1 BAG; Type 0: Not a Combination Product	06/01/2018
3	NDC: 54305-153-45	45 in 1 BAG; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2018

Labeler - Ricola Ag (480227248)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		485393768	manufacture(54305-153)

Establishment
Name	Address	ID/FEI	Business Operations
Associated Production Services		078319934	repack(54305-153)