HERBON SUGAR FREE LEMON HONEY- menthol and echinacea purpurea lozenge

Herbon Sugar Free Lemon Honey by

Drug Labeling and Warnings

Herbon Sugar Free Lemon Honey by is a Otc medication manufactured, distributed, or labeled by Purity Life Division of SunOpta Co., 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. Soothes throat irritation. 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) .................................8 mg

INACTIVE INGREDIENT

Non-medicinal Ingredients: Natural flavours (honey lemon, lemon), natural colours (beta carotene, curcumin), citric acid, isomalt, xylitol.

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 - 18 Lozenge Bag

Herbon®

ECHINACEA Cough and Sore Throat Drops

Sugar-Free

Temporary Relief of
Cough & Sore Throat
Helps Ease Nasal Congestion

ALL NATURALLY-SOURCED
ACTIVE INGREDIENTS

LEMON HONEY

REFRESHING
BURSTS
of LEMON

18 Lozenges

INGREDIENTS AND APPEARANCE

HERBON SUGAR FREE LEMON HONEY 
menthol and echinacea purpurea lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44597-5535
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	8 mg
Echinacea Purpurea (UNII: QI7G114Y98) (Echinacea - UNII:4N9P6CC1DX)	Echinacea	7.35 mg

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)	16.93 mg
Xylitol (UNII: VCQ006KQ1E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44597-5535-0	12 in 1 CARTON
1		18 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 Co. (243105843)

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

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