NDC 72628-108 Menthol Vapor Cough Drops

Menthol

NDC Product Code 72628-108

NDC 72628-108-01

Package Description: 45 PASTILLE in 1 BAG

NDC Product Information

Menthol Vapor Cough Drops with NDC 72628-108 is a a human over the counter drug product labeled by Boston Nutraceutical Production, S.l. The generic name of Menthol Vapor Cough Drops is menthol. The product's dosage form is pastille and is administered via oral form.

Labeler Name: Boston Nutraceutical Production, S.l

Dosage Form: Pastille - An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.

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.

Menthol Vapor 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 20 mg/1

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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ACACIA (UNII: 5C5403N26O)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)
  • CORN SYRUP (UNII: 9G5L16BK6N)

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.
  • 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: Boston Nutraceutical Production, S.l
Labeler Code: 72628
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: 06-01-2020 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: 12-31-2021 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.

Menthol Vapor Cough Drops Product Label Images

Menthol Vapor 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 PurposesMenthol 20 mgSevereMenthol Caugh SuppressantOral Anesthetic

Otc - Purpose

  • PurposesTemporarily relieves ocassional minor irritation and pain due to:sore throatsore mouth

Indications & Usage

  • PurposesTemporarily relieves ocassional minor irritation and pain due to:sore throatsore mouth

Warnings

WarningsSore throat warning: severe or persistent throat accompanied by high fever headache, nausea and vomiting maybe serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of old.

Otc - Ask Doctor

  • Ask a doctor before use if you haveA severe throat accompanied by difficulty in breathing or that last more than 2 daysA severe throat accompanied by fever, headache, rash, swealling, nausea or vomiting.

Otc - Stop Use

  • Stop use and consult doctor ifsore mouth symptons does not improve in 7 days or if irritation, pain or redness persists or worseIf pregnant or breast feeding, ask a health professional before use.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Overdosage

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsAdults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every two hours as needed or as directed by a doctor.Children 12 years or under do not use

Other Safety Information

  • Other informationStore in a cool and dry place

Inactive Ingredient

Corn syrup, sucrose, water, eucalyptus oil, acacia, FD&Blue No.1

Otc - Questions

Questions or comments call: 1-888-423-0139

* Please review the disclaimer below.