NDC 15631-0267 Lappa Major

Lappa Major

NDC Product Code 15631-0267

NDC 15631-0267-0

Package Description: 100 PELLET in 1 VIAL, SINGLE-DOSE

NDC 15631-0267-1

Package Description: 200 PELLET in 1 PACKAGE

NDC 15631-0267-2

Package Description: 400 PELLET in 1 PACKAGE

NDC 15631-0267-3

Package Description: 750 PELLET in 1 PACKAGE

NDC 15631-0267-4

Package Description: 2500 PELLET in 1 PACKAGE

NDC 15631-0267-5

Package Description: 12500 PELLET in 1 PACKAGE

NDC Product Information

Lappa Major with NDC 15631-0267 is a a human over the counter drug product labeled by Rxhomeo Private Limited D.b.a. Rxhomeo, Inc. The generic name of Lappa Major is lappa major. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Rxhomeo Private Limited D.b.a. Rxhomeo, Inc

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Lappa Major 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.

  • ARCTIUM LAPPA ROOT 1 [hp_X]/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.

  • SUCROSE (UNII: C151H8M554)

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: Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Labeler Code: 15631
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 09-05-2015 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: 12-31-2018 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: E 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.

Lappa Major Product Label Images

Lappa Major 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

LAPPA MAJOR HPUS 1X and higher

Uses

Acne Of The Head

Indications

Condition listed above or as directed by the physician

Dosage

Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

Warnings

This product is to be used for self-limiting conditions

Otc - Stop Use

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of reach of children

Otc - Do Not Use

Do not use if capseal is broken or missing. Close the cap tightly after use.

Inactive Ingredients

Sucrose

Storage

Store in a cool dark place

* Please review the disclaimer below.

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