HERBON SUGAR FREE 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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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

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

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 BAG IS OPEN OR TORN.

STORE IN A COOL, DRY PLACE.

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

Principal Display Panel
HERBON SUGAR FREE LEMON HONEY 
menthol and echinacea purpurea lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44597-5535
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol8 mg
Echinacea Purpurea (UNII: QI7G114Y98) (Echinacea - UNII:4N9P6CC1DX) Echinacea7.35 mg
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP) 16.93 mg
Xylitol (UNII: VCQ006KQ1E)  
Product Characteristics
ColorYELLOW (Transulucent golden yellow with opaque yellow speckles) Scoreno score
ShapeROUNDSize20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44597-5535-012 in 1 CARTON
118 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2009
Labeler - Purity Life Division of SunOpta Co. (243105843)
Establishment
NameAddressID/FEIBusiness Operations
Purity Life Division of SunOpta Co.243105843RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
F&F Laboratories Inc.005092838MANUFACTURE

Revised: 10/2009
Document Id: fad6077b-2fc9-4017-b8f8-b9b95ccb5856
Set id: b27e7413-5009-42ec-9175-33015046413a
Version: 2
Effective Time: 20091015
 
Purity Life Division of SunOpta Co.