HERBON ROCKHOPPER CHOCOMINT - 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. Helps ease 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) ...................................6.5 mg

Non-medicinal Ingredients: Natural flavours (chocolate, peppermint, wintermint), natural colour (carmine), corn syrup, sugar, cocoa powder.

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 - 20 Lozenge Bag

Herbon®

ROCKHOPPERSTM/MC

ECHINACEA Cough and Sore Throat Drops

Temporary Relief of
Cough & Sore Throat
Helps Ease Nasal
Congestion

ALL NATURALLY-SOURCED
ACTIVE INGREDIENTS

CHOCOMINT

REFRESHING
BURSTS
of WINTERMINT

20 Lozenges

Principal Display Panel - 20 Lozenge Bag

PRINCIPAL DISPLAY PANEL - 10 Lozenge Bag

Herbon®

ROCKHOPPERSTM/MC

ECHINACEA Cough and Sore Throat Drops

ALL NATURALLY-SOURCED
ACTIVE INGREDIENTS

CHOCOMINT

10 Lozenges

Principal Display Panel - 10 Lozenge Bag

HERBON ROCKHOPPER CHOCOMINT 
menthol and echinacea purpurea lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44597-5550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol6.5 mg
Echinacea Purpurea (Echinacea Purpurea) Echinacea Purpurea7.35 mg
Inactive Ingredients
Ingredient NameStrength
Cocoa16.38 mg
Sucrose 
Corn Syrup 
Product Characteristics
ColorBROWN (Slightly opaque deep brown with deep pink speckles) Score no score
ShapeROUNDSize20mm
FlavorCHOCOLATE, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:44597-5550-112 BAG in 1 CARTONcontains a BAG
120 LOZENGE in 1 BAGThis package is contained within the CARTON (44597-5550-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/200912/31/2010

HERBON ROCKHOPPER CHOCOMINT 
menthol and echinacea purpurea lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44597-5655
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol6.5 mg
Echinacea Purpurea (Echinacea Purpurea) Echinacea Purpurea7.35 mg
Inactive Ingredients
Ingredient NameStrength
Cocoa16.38 mg
Sucrose 
Corn Syrup 
Product Characteristics
ColorBROWN (Slightly opaque deep brown with deep pink speckles) Score no score
ShapeROUNDSize20mm
FlavorCHOCOLATE, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:44597-5655-212 BAG in 1 CARTONcontains a BAG
110 LOZENGE in 1 BAGThis package is contained within the CARTON (44597-5655-2)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/200912/31/2010

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

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