HERBION NATURALS HONEY-LEMON COUGH DROPS- menthol lozenge 
Herbion Pakistan (Pvt.) Ltd.

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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Active Ingredient (in each drop)

Menthol, 1.6 mg

Purpose

Cough Suppresant, Oral Anesthetic

Uses

Warnings

  • 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

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

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)

Revised: 12/2012
Document Id: 80f2c4e7-f566-428e-89e0-5947102d3d25
Set id: 5f80af07-ea8c-496f-ae5d-179c01e50c63
Version: 2
Effective Time: 20121205
 
Herbion Pakistan (Pvt.) Ltd.