Label: HERBION NATURALS HONEY-LEMON COUGH DROPS- menthol lozenge

  • 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 December 5, 2012

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  • Active Ingredient (in each drop)

    Menthol, 1.6 mg

  • Purpose

    Cough Suppresant, Oral Anesthetic

  • Uses

    • Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.
  • Warnings

    • A persistent cough may be a sign of a serious condition.  If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • If breast-feeding or pregnant, consult your physician before using.

    • Keep this and all drugs out of the reach of children.
  • Directions

                Adults and children 12 years and over: Take 1-2 drops every 2 to 3 hours.
                Children 6 years to under 12 years: Take 1 drop every 5 to 6 hours not more than 4 drops in 24 hours               
                Children under 6 years of age:  Consult your doctor.              
                   
  • Other Information

    • Store in a cool, dry place, below 77 degrees F.
    • Protect from heat and light.
    • Diabetic patients should not use Herbion drops without the advice of physician and they should monitor glucose level closely while taking drops as it may alter blood-glucose levels.
  • Inactive Ingredients

    Ascorbic Acid, Citric Acid, Eucalyptus Oil, Honey-Lemon Flavor, Hyssop, Large-leaf Geiger Tree Fruit, Lesser Galangal Rhizome, Licorice Root, Long Pepper Fruit, Malabar Nut Leaf, Cane Sugar, Sweet Violet Leaf and Flower, Water

  • Side Panel:

    Manufactured for:
    Herbion USA Inc.
    Williamsville, NY 14221
    1-888-(OK-HERBION)-654-3724
    Info.us@herbion.com
    www.herbion.com

  • Principal Display Panel:

    Herbion Naturals

    Relieves Cough and Soothes Sore Throat

    All Natural

    Cough Drops

    Herbal Formula

    Honey Lemon

    18 Drops

    Honey Lemon Drops Carton

  • INGREDIENTS AND APPEARANCE
    HERBION NATURALS  HONEY-LEMON COUGH DROPS
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    LESSER GALANGAL ROOT (UNII: 42LD90786Y)  
    LICORICE (UNII: 61ZBX54883)  
    LONG PEPPER (UNII: 2NMG4EA7B1)  
    JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)  
    SUCROSE (UNII: C151H8M554)  
    VIOLA ODORATA LEAF (UNII: 3X41NMU9FW)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize17mm
    FlavorHONEY, LEMONImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44237-008-182 in 1 CARTON
    19 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2013
    Labeler - Herbion Pakistan (Pvt.) Ltd. (645482936)
    Registrant - Herbion Pakistan (Pvt.) Ltd. (645482936)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbion Pakistan (Pvt.) Ltd.645482936relabel(44237-008) , manufacture(44237-008)
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