Label: HERBON GLACIAL MINT- echinacea purpurea, menthol, and eucalyptus oil lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 44597-5505-1 - Packager: Purity Life Division of SunOpta
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 9, 2009
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- INDICATIONS AND USAGE
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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.
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Medicinal Ingredients:
Each lozenge contains:
Echinacea (Echinacea purpurea) root extract 22:1
(equivalent to 162 mg dried herb) ................................7.35 mgMenthol (from Mentha arvensis leaf) ...................................10 mg
Eucalyptus oil (Eucalyptus globulus) .....................................6 mg
- INACTIVE INGREDIENT
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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
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - 20 Lozenge Bag
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INGREDIENTS AND APPEARANCE
HERBON GLACIAL MINT
echinacea purpurea, menthol, and eucalyptus oil lozengeProduct 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