HERBON GLACIAL MINT- echinacea purpurea, menthol, and eucalyptus oil lozenge

Herbon Glacial Mint by

Drug Labeling and Warnings

Herbon Glacial Mint by is a Otc medication manufactured, distributed, or labeled by Purity Life Division of SunOpta, F&F Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS AND USAGE

Recommended Use: For the temporary relief of cough and sore throat pain. Helps relieve nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold.

Recommended Dose:

Adolescents (10 to 14 years): Dissolve 1 lozenge slowly in the mouth three times daily or more as needed.

Adults and adolescents (14 years and older): Dissolve 1 lozenge slowly in the mouth six times daily or more as needed.

Note: Do not exceed 14 lozenges per day. Consult a health care practitioner for use beyond eight weeks.

Medicinal Ingredients:

Each lozenge contains:

Echinacea (Echinacea purpurea) root extract 22:1
  (equivalent to 162 mg dried herb) ................................7.35 mg

Menthol (from Mentha arvensis leaf) ...................................10 mg

Eucalyptus oil (Eucalyptus globulus) .....................................6 mg

INACTIVE INGREDIENT

Non-medicinal Ingredients: Natural flavours (lemon, wintermint), natural colours (alfalfa, carmine, curcumin), corn syrup, sugar.

WARNINGS

Risk Information: Consult a health care practitioner if symptoms persist or worsen, if sore throat symptoms are severe or persist for more than two days, if cough worsens, persists for more than seven days or is accompanied by high fever. Consult a health care practitioner prior to use if you take immunosuppressants or have a progressive systemic disease such as tuberculosis, leukosis, collagenosis or multiple sclerosis.

DO NOT USE

DO NOT USE IF BAG IS OPEN OR TORN.

STORAGE AND HANDLING

STORE IN A COOL, DRY PLACE.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL - 20 Lozenge Bag

Herbon®

ECHINACEA Cough and Sore Throat Drops

Original

Temporary Relief of
Cough & Sore Throat
Helps Ease Nasal Congestion

ALL NATURALLY-SOURCED
ACTIVE INGREDIENTS

Extra Strength

GLACIAL MINT

REFRESHING
BURTS
of LEMON and
WINTERMINT

20 Lozenges

INGREDIENTS AND APPEARANCE

HERBON GLACIAL MINT 
echinacea purpurea, menthol, and eucalyptus oil lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44597-5505
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Echinacea Purpurea (UNII: QI7G114Y98) (Echinacea - UNII:4N9P6CC1DX)	Echinacea	7.35 mg
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	10 mg
Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662)	Eucalyptus Oil	6 mg

Inactive Ingredients
Ingredient Name	Strength
Sucrose (UNII: C151H8M554)	2150.04 mg
Corn Syrup (UNII: 9G5L16BK6N)

Product Characteristics
Color	YELLOW (Slightly opaque light yellowish green with deep pink and bright yellow speckles)	Score	no score
Shape	ROUND	Size	20mm
Flavor	LEMON (lemon, wintermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44597-5505-1	12 in 1 CARTON
1		20 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/30/2009

Labeler - Purity Life Division of SunOpta (243105843)

Establishment
Name	Address	ID/FEI	Business Operations
Purity Life Division of SunOpta		243105843	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
F&F Laboratories Inc.		005092838	MANUFACTURE