NDC 57631-205 Herbomint Cough Drops

Menthol

NDC Product Code 57631-205

NDC 57631-205-29

Package Description: 100 LOZENGE in 1 PACKAGE

NDC Product Information

Herbomint Cough Drops with NDC 57631-205 is a a human over the counter drug product labeled by Invatech Pharma Solutions Llc. The generic name of Herbomint Cough Drops is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Invatech Pharma Solutions Llc

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.

Herbomint 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 9.99 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.

  • CARDAMOM (UNII: 8BC4CUT4JL)
  • CARAMEL (UNII: T9D99G2B1R)
  • BASIL (UNII: 2U0KZP0FDW)
  • LICORICE (UNII: 61ZBX54883)
  • ACACIA CATECHU WHOLE (UNII: TJ6XA84OQF)
  • MALABAR PLUM JUICE (UNII: 58D570WY62)
  • CLOVE (UNII: K48IKT5321)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • RAW SUGAR (UNII: 8M707QY5GH)

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: Invatech Pharma Solutions Llc
Labeler Code: 57631
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: 05-22-2019 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.

Herbomint Cough Drops Product Label Images

Herbomint 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

Active Ingredient

Menthol (From Mentha spicata) (in each 3gm Drop of Serving Size)....................................................9.99 mg

Uses

Natural way of calming cough and soothing sore throats

Warnings

Sore throat warnings: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.


Do not use for children under 6 years of age unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough 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 daysirritation, pain, or redness persist or worsens

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as if needed or as directed by a doctorchildren under 6 years: ask a doctordo not bite or chew

Other Information

Protect from heat and moisture

Inactive Ingredients

Holy Basil, Liquorice, Acacia catechu, Malabar, Cardamom, Clove, eucalyptus oil, caramel color q.s sugar base q.s

Purpose

Natural way of calming cough and soothing sore throats

* Please review the disclaimer below.

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