Theraproxen-90
Theraproxen-90
29acd686-ca11-42b0-b5cd-5c1a04e45c29
HUMAN PRESCRIPTION DRUG LABEL
Aug 1, 2011
Physician Therapeutics LLC
DUNS: 931940964
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
DESCRIPTION SECTION
PRODUCT DESCRIPTION
Primary Ingredients Theramine consists of a proprietary blend of amino acids, cocoa, caffeine, cinnamon, and flavonoids in specific proportions. These ingredients fall into the category of Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.
Amino Acids
Amino Acids are the building blocks of protein. All amino acids are GRAS
listed as they have been ingested by humans for thousands of years. The doses
of the amino acids in Theramine are equivalent to those found in the usual
human diet. Patients with pain disorders may require an increased amount of
certain amino acids that cannot be obtained from normal diet alone.
Tryptophan, for example, is an obligatory amino acid. The body cannot make
tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to
produce serotonin. Serotonin is required to reduce pain. Patients with pain
disorders and inflammatory conditions have altered serotonin metabolism. Some
patients with pain disorders and inflammatory conditions have a resistance to
the use of tryptophan that is similar to the mechanism found in insulin
resistance. Patients with pain disorders and inflammatory conditions cannot
acquire sufficient tryptophan from the diet to alter the perception of pain
and the inflammatory process without ingesting a prohibitively large amount of
calories, particularly calories from protein.
Flavonoids
Flavonoids are a group of phytochemical compounds found in all vascular plants
including fruits and vegetables. They are a part of a larger class of
compounds known as polyphenols. Many of the therapeutic or health benefits of
colored fruits and vegetables, cocoa, red wine, and green tea are directly
related to their flavonoid content. The specially formulated flavonoids found
in Theramine cannot be obtained from conventional foods in the necessary
proportions to elicit a therapeutic response.
Other Ingredients
Theramine contains the following inactive or other ingredients, as fillers,
excipients, and colorings: magnesium stearate, microcrystalline cellulose,
Maltodextrin NF, gelatin (as the capsule material).
Physical Description
Theramine is a yellow to light brown powder. Theramine contains L-Glutamine,
L-Arginine, L-Histidine, and L-Serine, 5-Hydroxytryptophan as Griffonia Seed
Extract, GABA, Choline Bitartrate, Cinnamon, Cocoa, Hydrolyzed Whey Protein,
and Grape Seed Extract.