RICOLA MAX THROAT CARE COOL PEPPERMINT- menthol lozenge

RICOLA MAX THROAT CARE COOL PEPPERMINT by

Drug Labeling and Warnings

RICOLA MAX THROAT CARE COOL PEPPERMINT by is a Otc medication manufactured, distributed, or labeled by Ricola USA Inc., Ricola Ag . 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.

Ask doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
• sore mouth does not improve in 7 days
• irritation, pain, or redness persists or worsens

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
• do not bite or chew

Other Information

Store in a dry place

Inactive Ingredients

extract 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RICOLA MAX THROAT CARE COOL PEPPERMINT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63667-202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.3 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	24mm
Flavor	PEPPERMINT	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63667-202-34	34 in 1 BAG; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2022

Labeler - Ricola USA Inc. (177265261)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		485393768	manufacture(63667-202)