NDC 15631-0595 Guaiacum

Product Information

Product Code15631-0595
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.
Guaiacum
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
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.
01-07-2016
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.
12-31-2018
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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)3 MM
Score1

Product Packages

NDC 15631-0595-0

Package Description: 1 TABLET in 1 BLISTER PACK

NDC 15631-0595-1

Package Description: 4 TABLET in 1 BLISTER PACK

NDC 15631-0595-2

Package Description: 50 TABLET in 1 CONTAINER

NDC 15631-0595-3

Package Description: 100 TABLET in 1 CONTAINER

NDC 15631-0595-4

Package Description: 250 TABLET in 1 CONTAINER

NDC 15631-0595-5

Package Description: 500 TABLET in 1 CONTAINER

NDC 15631-0595-6

Package Description: 1000 TABLET in 1 CONTAINER

NDC 15631-0595-7

Package Description: 10000 TABLET in 1 CONTAINER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Guaiacum is product labeled by Rxhomeo Private Limited D.b.a. Rxhomeo, Inc. The product's dosage form is and is administered via form.


What are Guaiacum Active Ingredients?

The following is the list of active ingredients in this product. 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.

  • GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6)
  • GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (Active Moiety)


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.

  • LACTOSE (UNII: J2B2A4N98G)


* Please review the disclaimer below.

Guaiacum 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



GUAIACUM HPUS 1X and Higher


Uses



Rheumatic Pain


Indications



Condition listed above or as directed by the physician.


Dosage



Adults- Take 4 or 6 Tablets 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



Lactose


Storage



Store in a cool dark place


Questions Or Comments



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

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


Package Label.Principal Display Panel




* Please review the disclaimer below.