SUGAR FREE LEMON MINT HERB THROAT DROPS- menthol lozenge

SUGAR FREE LEMON MINT HERB THROAT DROPS by

Drug Labeling and Warnings

SUGAR FREE LEMON MINT HERB THROAT DROPS 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

Oral anesthetic

Active Ingredient (in each drop)

Menthol, 1.1 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 3 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

• Phenylketonurics: contains phenylalanine 1 mg per drop
• excessive use may have a laxative effect
• store in a dry place
• product may be useful for diabetics on the advice of a doctor

Exchange information:   2 Drops = FREE Exchange

                                                7 Drops = 1 Fruit

Dietary exchanges based on Exchange Lists for Diabetics

© 2008 American Diabetes Association, American Dietetic Association

Inactive Ingredients

ascorbic acid (vitamin C), aspartame, citric acid, extracts of lemon balm and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural color (beta-carotene), natural flavors

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUGAR FREE LEMON MINT HERB THROAT DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63667-956
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.1 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISOMALT (UNII: S870P55O2W)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Product Characteristics
Color	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: 63667-956-19	19 in 1 BAG; Type 0: Not a Combination Product	01/01/1942
2	NDC: 63667-956-95	105 in 1 BAG; Type 0: Not a Combination Product	01/01/1942	12/29/2017
3	NDC: 63667-956-24	24 in 1 BAG; Type 0: Not a Combination Product	01/01/1942
4	NDC: 63667-956-45	45 in 1 BAG; Type 0: Not a Combination Product	01/01/1942

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 USA Inc. (177265261)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		480227248	manufacture(63667-956)