HERBION NATURALS ORANGE - 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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Drug Facts

Active Ingredient (in each drop):

Menthol, 5.5mg

Purpose

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

Uses

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


Stop use and ask a doctor if

Keep out of reach of children.

Directions


Other Information


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

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)

Revised: 11/2013
Document Id: 37c61a09-9bee-4b5f-9642-bf6bcb302e28
Set id: d5a98bf3-c5e9-4939-bbff-f3d09c6bae30
Version: 3
Effective Time: 20131121
 
Herbion Pakistan (Pvt.) Ltd