ORGANIC PEPPERMINT HERB THROAT DROPS- menthol lozenge

ORGANIC PEPPERMINT HERB THROAT DROPS by

Drug Labeling and Warnings

ORGANIC PEPPERMINT HERB THROAT DROPS by is a Otc medication manufactured, distributed, or labeled by Ricola Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Oral anesthetic

Active Ingredient (in each drop)

Menthol, 1.9 mg

Uses

temporarily relieves occasional minor irritation and pain associated with:

• sore mouth
• sore throat

Warnings

Do not use

• in children under 6 years of age unless directed by a doctor.

Stop use and ask a doctor if

• sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.
• sore mouth symptoms do not improve in 7 days.

Keep out of reach of children.

Directions

• adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  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 (ribwort plantain, lady's mantle, mallow, thyme, pimpinella, marshmallow, peppermint), peppermint oil, starch syrup, sugar

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORGANIC PEPPERMINT HERB THROAT DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54305-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.9 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	brown (BROWN)	Score	no score
Shape	OVAL	Size	24mm
Flavor	PEPPERMINT (PEPPERMINT)	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54305-010-15	15 in 1 BAG; Type 0: Not a Combination Product	12/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/02/2019

Labeler - Ricola Ag (480227248)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		480227248	manufacture(54305-010)