NDC 44237-020 Herbion Naturals Orange Cough Drops

NDC Product Code 44237-020

NDC 44237-020-16

Package Description: 2 BLISTER PACK in 1 CARTON > 9 LOZENGE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Herbion Naturals Orange Cough Drops with NDC 44237-020 is a product labeled by Herbion Pakistan (pvt) Ltd. The generic name of Herbion Naturals Orange Cough Drops is . The product's dosage form is and is administered via form.

Labeler Name: Herbion Pakistan (pvt) Ltd

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Herbion Pakistan (pvt) Ltd
Labeler Code: 44237
Start Marketing Date: 01-01-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Herbion Naturals Orange Cough Drops Product Label Images

Herbion Naturals Orange Cough Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredient (in each drop):Menthol, 5.5mg

Otc - Purpose

Purpose:Cough suppressant / Oral Anesthetic

Indications & Usage

  • Uses:temporarily relieves cough due to minor throat and bronchial irritation associated with the common coldfor 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

Otc - Ask Doctor

Ask a doctor before use if you have:persistent or chronic cough such as occurs with smoking, asthma or emphysemacough that is accompanied by excessive phlegm (mucus)

Otc - 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 conditionsore mouth does not improve in 7 daysirritation, pain or redness persists or worsens

Otc - 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 doctorchildren 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 levelsstore in a cool, dry place, below 77°Fprotect from heat and light

Inactive Ingredient

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

Otc - Questions

Questions or Comments?1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5am

* Please review the disclaimer below.