HERBON ORIGINAL LEMON HONEY - menthol and echinacea purpurea lozenge
Purity Life Division of SunOpta Co.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RECOMMENDED USE: FOR THE TEMPORARY RELIEF OF COUGH AND SORE THROAT.

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 CONSULT A HEALTH CARE PRACTITIONER FOR USE BEYOND 8 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) 8 MG.

NON-MEDICINAL INGREDIENTS: NATURAL FLAVOURS (HONEY LEMON, LEMON), NATURAL COLOURS (BETA CAROTENE, CURCUMIN), CITRIC ACID, CORN SYRUP, SUGAR, HONEY.

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 IF PACKAGE IS OPEN OR TORN.

KEEP OUT OF REACH OF CHILDREN.

STORE IN A COOL, DRY PLACE.

PRINCIPAL DISPLAY PANEL - 10 Lozenges

Herbon®

ECHINACEA Cough and Sore Throat Drops
Original

ALL NATURALLY-SOURCED
ACTIVE INGREDIENTS

LEMON HONEY

10 Lozenges

HERBON ORIGINAL LEMON HONEY
menthol and echinacea purpurea lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44597-5675
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (Menthol)	Menthol	8 mg
Echinacea Purpurea (Echinacea Purpurea)	Echinacea Purpurea	7.35 mg

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate	18.71 mg
Sucrose
Corn Syrup
Honey

Product Characteristics
Color	YELLOW (Transulucent golden yellow with opaque yellow speckles)	Score	no score
Shape	ROUND	Size	20mm
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:44597-5675-2	12 PACKAGE, COMBINATION in 1 CARTON	contains a PACKAGE, COMBINATION
1		10 LOZENGE in 1 PACKAGE, COMBINATION	This package is contained within the CARTON (44597-5675-2)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/30/2009	12/31/2010

Labeler - Purity Life Division of SunOpta Co. (243105843)

Revised: 06/2012 Purity Life Division of SunOpta Co.