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 November 3, 2015

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

  • ACTIVE INGREDIENT

    Active ingredient (in each drop):

    Menthol, 5.5mg

  • PURPOSE

    Purpose:

    Cough suppressant / Oral Anesthetic

  • INDICATIONS & USAGE

    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 DOCTOR

    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)
  • DO NOT USE

    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

  • DOSAGE & ADMINISTRATION

    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
  • GENERAL PRECAUTIONS

    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 INGREDIENT

    Inactive Ingredients:

    Ascorbic Acid, Natural honey  flavor, Natural lemon 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

    Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL

    Loz HL 9s

  • INGREDIENTS AND APPEARANCE
    HERBION NATURALS HONEY LEMON COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.5 mg  in 2.5 
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    HYSSOPUS OFFICINALIS WHOLE (UNII: 0IQW001KPE)  
    CORDIA SEBESTENA FLOWER (UNII: LM8F18O4OJ)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    LONG PEPPER (UNII: 2NMG4EA7B1)  
    JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize17mm
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44237-023-091 in 1 CARTON
    19 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/03/2015
    Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)
    Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbion Pakistan (Pvt.) Ltd645482936manufacture(44237-023)