HERBION NATURALS ORANGE COUGH DROPS- menthol lozenge

Herbion Naturals Orange Cough Drops by

Drug Labeling and Warnings

Herbion Naturals Orange Cough Drops 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

Active ingredient (in each drop):

Menthol, 5.5mg

PURPOSE

Purpose:

Cough suppressant / Oral Anesthetic

INDICATIONS & USAGE

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 DOCTOR

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)

DO NOT USE

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

DOSAGE & ADMINISTRATION

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

GENERAL PRECAUTIONS

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 INGREDIENT

Inactive Ingredients:

Natural Orange flavor, Eucalyptus oil, Greater galangal Rhizome, Hyssop, Large-leaf geiger tree Fruit, Licorice Root, Long pepper Fruit, Malabar nut tree Leaf, Cane sugar, Liquid glucose, Ascorbic Acid, Citric acid       

QUESTIONS

Questions or Comments?

1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm (EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HERBION NATURALS ORANGE COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-031
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.5 mg  in 2.5

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	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: 44237-031-25	25 in 1 POUCH	08/31/2016
1		25 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/31/2016

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-031)