NDC 15631-0404 Silicea
Pellet Oral

Product Information

Silicea is a human over the counter drug product labeled by Rxhomeo Private Limited D.b.a. Rxhomeo, Inc. The product's dosage form is pellet and is administered via oral form.

Product Code15631-0404
Proprietary Name 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.
Silicea
Non-Proprietary Name 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.
Silicea
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.
Human Otc Drug
Dosage FormPellet - 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.
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.
Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Labeler Code15631
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-02-2015
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Silicea?


Product Packages

NDC 15631-0404-0

Package Description: 100 PELLET in 1 PACKAGE

NDC 15631-0404-1

Package Description: 200 PELLET in 1 PACKAGE

NDC 15631-0404-2

Package Description: 400 PELLET in 1 PACKAGE

NDC 15631-0404-3

Package Description: 750 PELLET in 1 PACKAGE

NDC 15631-0404-4

Package Description: 2500 PELLET in 1 PACKAGE

NDC 15631-0404-5

Package Description: 12500 PELLET in 1 PACKAGE

NDC 15631-0404-6

Package Description: 500 PELLET in 1 PACKAGE

NDC 15631-0404-7

Package Description: 1000 PELLET in 1 PACKAGE

Product Details

What are Silicea Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SILICON DIOXIDE 2 [hp_X]/1 - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.

Silicea Active Ingredients UNII Codes

Silicea Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Silicea Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



SILICEA HPUS 2X and higher


Uses



Boils, Abscess, Otitis


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 pregnant, 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


Questions Or Comments



www.Rxhomeo.com | 1.888.2796642 | [email protected]

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758


* Please review the disclaimer below.