NDC 44237-034 Herbion Naturals Ivy Leaf Cough Drops

Menthol

NDC Product Code 44237-034

NDC Code: 44237-034

Proprietary Name: Herbion Naturals Ivy Leaf Cough Drops What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 44237 - Herbion Pakistan (pvt.) Ltd
    • 44237-034 - Herbion Naturals Ivy Leaf Cough Drops

NDC 44237-034-25

Package Description: 25 POUCH in 1 POUCH > 25 LOZENGE in 1 POUCH

NDC Product Information

Herbion Naturals Ivy Leaf Cough Drops with NDC 44237-034 is a a human over the counter drug product labeled by Herbion Pakistan (pvt.) Ltd. The generic name of Herbion Naturals Ivy Leaf Cough Drops is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Herbion Pakistan (pvt.) Ltd

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

Product Type: Human Otc Drug 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.


Herbion Naturals Ivy Leaf Cough Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 5.5 mg/2.51

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)
  • SUCROSE (UNII: C151H8M554)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
  • THYMUS VULGARIS LEAF (UNII: GRX3499643)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

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
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-04-2019 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: 12-31-2020 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: N 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 Ivy Leaf Cough Drops Product Label Images

Herbion Naturals Ivy Leaf 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, 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 warningIf 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:there is persistent or chronic cough such as occurs with smoking, asthma or emphysemacough is accompanied by excessive phlegm (mucus)breast-feeding or pregnant

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 6 years of age and over Dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctorchildren under 6 years of age: consult a doctor

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:Ivy Leaf Powder Extract, Thyme Powder Extract, Licorice Powder Extract, Natural honey flavor, Natural lemon flavor, Sugar, Monoammonium Glycyrrhizinate, Liquid glucose, Ascorbic Acid, Citric acid

Otc - Questions

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

* Please review the disclaimer below.

Previous Code
44237-033
Next Code
44237-100