HERBION NATURALS MINT  - 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


  • 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 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

  • 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.

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

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 Ingredients

Ascorbic Acid, Artificial Honey Flavor, Artificial Lemon Flavor, Artificial Mint Flavor, Artificial Yellow Color, Artificial Brown Color, 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


Principal Display Panel

Herbion Naturals

Relieves Cough and Soothes Sore Throat

NATURAL CARE

cough drops

Menthol

-Cough Suppressant            Honey Lemon
-Oral Anesthetic                   18 Drops

Herbion Honey Lemon label
HERBION NATURALS MINT  
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:44237-300
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.5 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
DEXTROSE 
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
JUSTICIA ADHATODA LEAF 
LONG PEPPER 
CORDIA SEBESTENA FLOWER 
GREATER GALANGAL 
HYSSOPUS OFFICINALIS WHOLE 
GLYCYRRHIZA GLABRA 
Product Characteristics
Coloryellow, brownScoreno score
ShapeROUNDSize17mm
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44237-300-182 in 1 CARTON
19 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/24/2013
Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)
Establishment
NameAddressID/FEIBusiness Operations
Herbion Pakistan (Pvt.) Ltd645482936manufacture(44237-300)

Revised: 11/2013
 
Herbion Pakistan (Pvt.) Ltd