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 mg

Purpose

Cough Suppresant, Oral Anesthetic

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.

Warnings

  • A persistent cough may be a sign of a serious condition.  If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • If breast-feeding or pregnant, consult your physician before using.

  • 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

  • Store in a cool, dry place, below 77 degrees F.
  • Protect from heat and light.
  • Diabetic patients should not use Herbion drops without the advice of physician and they should monitor glucose level closely while taking drops as it may alter blood-glucose levels.

Inactive Ingredients

Ascorbic Acid, Citric Acid, Eucalyptus Oil, Orange 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

Orange

18 Drops

Orange Drops Carton


HERBION NATURALS  ORANGE COUGH DROPS
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:44237-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
HYSSOPUS OFFICINALIS FLOWERING TOP 
LESSER GALANGAL ROOT 
LICORICE 
LONG PEPPER 
JUSTICIA ADHATODA LEAF 
SUCROSE 
VIOLA ODORATA LEAF 
WATER 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize17mm
FlavorMINTImprint Code ;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44237-010-182 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(44237-010), manufacture(44237-010)

Revised: 12/2012
 
Herbion Pakistan (Pvt.) Ltd.