HERBION NATURALS ORANGE 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, 5.5mg

Purpose:

Cough suppressant / Oral Anesthetic

Uses:

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:

keep out of reach of children

Directions:

Other Information:

Inactive Ingredients:

Ascorbic Acid, Natural 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 - 5am

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HERBION NATURALS ORANGE COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-020
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
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44237-020-162 in 1 CARTON
19 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2015
Labeler - Herbion Pakistan (Pvt) Ltd (645482936)
Registrant - Herbion Pakistan (Pvt) Ltd (645482936)
Establishment
NameAddressID/FEIBusiness Operations
Herbion Pakistan (Pvt) Ltd645482936manufacture(44237-020)

Revised: 1/2015
Document Id: 2084c617-9a09-4545-9418-8cb59ac53ba4
Set id: ff03c978-a837-49e2-9f2e-cade154998bc
Version: 1
Effective Time: 20150101
 
Herbion Pakistan (Pvt) Ltd