HERBION NATURALS ORANGE- menthol lozenge

Herbion Naturals Orange by

Drug Labeling and Warnings

Herbion Naturals Orange by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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

INGREDIENTS AND APPEARANCE

HERBION NATURALS ORANGE 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	5.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	ROUND	Size	17mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-100-18	2 in 1 CARTON
1		9 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2013

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-100)