Label: HERBION NATURALS ORANGE- 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 November 21, 2013

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each drop):

    Menthol, 5.5mg

  • Purpose

    Menthol, 5.5mg.........................Cough suppressant / Oral Anesthetic

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
    • for temporary relief of occasional minor irritation, pain, sore mouth and sore throat
  • Warnings

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.These may be serious

  • Ask a doctor before use if you have


    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough that is accompanied by excessive phlegm (mucus)
  • Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition
    • sore mouth does not improve in 7 days
    • irritation, pain or redness persists or worsens
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions


    • adults and children 2 years of age and over: Dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
    • children under 2 years of age: consult a physician
  • Other Information


    • diabetic patients should not use Herbion drops without the advice of a physician and they should monitor glucose levels closely while taking drops as they may alter blood-glucose levels
    • store in a cool, dry place, below 77°F
    • protect from heat and light
  • Inactive Ingredients

    Ascorbic Acid, Artificial Orange Color, Artificial Orange Flavor, Artificial Mint Flavor, Cane Sugar, Citric Acid, Eucalyptus Oil, Greater Galangal Rhizome, Hyssop, Large-leaf Geiger Tree Fruit, Licorice Root, Liquid Glucose, Long Pepper Fruit, Malabar Nut Tree Leaf.

  • Questions or Comments?


    1-888-(OK-HERBION) 654-3724, Monday through Friday, 9am - 5pm

  • Side Panel


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

    Made in Pakistan


  • Principal Display Panel

    Herbion Naturals

    Relieves Cough and Soothes Sore Throat

    NATURAL CARE

    cough drops

    Menthol

    -Cough suppressant            Orange
    -Oral anesthetic                  18 Drops

    Herbion Orange Drops Carton

  • INGREDIENTS AND APPEARANCE
    HERBION NATURALS ORANGE 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)  
    LONG PEPPER (UNII: 2NMG4EA7B1)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    HYSSOPUS OFFICINALIS WHOLE (UNII: 0IQW001KPE)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CORDIA SEBESTENA FLOWER (UNII: LM8F18O4OJ)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize17mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44237-100-182 in 1 CARTON
    19 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2013
    Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbion Pakistan (Pvt.) Ltd645482936manufacture(44237-100)