NATURAL LEMON MINT HERB THROAT DROPS- menthol lozenge

NATURAL LEMON MINT HERB THROAT DROPS by

Drug Labeling and Warnings

NATURAL LEMON MINT 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, 1.5 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.  Repeat every 2 hours as needed or as directed by a doctor
• children under 6 years: ask a doctor

Other Information

Store in a dry place

Inactive Ingredients

citric acid, extracts of lemon balm and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural color (beta-carotene), natural flavors, starch syrup, sugar

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURAL LEMON MINT HERB THROAT DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54305-489
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow (GOLDEN YELLOW)	Score	no score
Shape	OVAL	Size	24mm
Flavor	LEMON (LEMON MINT)	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54305-489-24	24 in 1 BAG; Type 0: Not a Combination Product	01/01/1942
2	NDC: 54305-489-30	30 in 1 BAG; Type 0: Not a Combination Product	01/01/1942	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/1942

Labeler - Ricola Ag (480227248)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		480227248	manufacture(54305-489)