Tobakient

Basic Information

Product Label

Product label for Tobakient
Full Name: Tobakient
Brand: Levins Pharma none
Product Type: Other Combinations
Physical State: Capsule
UPC/SKU: 3 71905 10030 1
Status: Off Market
Product Version Code: Rev. 01/19

Contact Information

Manufactured for

Name: Levins Pharmaceuticals, LLC
Address:15121 Lemoyne Blvd, Biloxi, MS, 39532
Phone: 228-392-0043
Types: Distributor

Product Details

Net Contents

30 Capsule(s)(30 Capsule(s))

Serving Sizes

Unit:Capsule(s)
Quantity:1 - 1
Daily Servings:1 - 2

Target Groups

Adult (18 - 50 Years)

Servings Per Container

30

Ingredients & Nutrition

AstaReal

non-nutrient/non-botanical

Group: Astaxanthin

Also known as: Astaxanthin

UNII Code: 0

Astaxanthin

non-nutrient/non-botanical

Group: Astaxanthin

Also known as: Zanthin Astaxanthin Complex, Zanthin, AstaZine, AstaReal, AstaREAL, Zanthin(R) Brand, Astaferm, BioAstin(R), SolAsta

UNII Code: 8XPW32PR7I

Group: Color

UNII Code: H3R47K3TBD

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Group: Collagen

Hydrolyzed collagen is a form of collagen that has been broken down into smaller peptides, ensuring ease of digestion and absorption in the human body. Collagen is the most abundant protein in the body and is essential for maintaining healthy skin, bones, and connective tissues. Hydrolyzed collagen is often used as a supplement to support skin health, joint health, and overall wellness.

Also known as: Gelatin

L-Glutathione

non-nutrient/non-botanical

Group: Gluthathione

Also known as: Setria, Setria brand, GSH, N-(N-L-Gamma-Glutamyl-L-Cysteinyl) Glycine

UNII Code: GAN16C9B8O

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

Group: Vitamin B6 (pyridoxine)

Pyridoxine, commonly known as Vitamin B6, is a water-soluble vitamin that plays a critical role in brain health, production of neurotransmitters, and the metabolism of proteins, fats, and carbohydrates. It is essential for the proper functioning of sugars, fats, and proteins in the body and is crucial for the development of the brain and nervous system.

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Riboflavin

vitamin

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B-2, vitamin B2, Vitamin B2, B2, activated B2, B-2, Vit. B2, pure powder B-2

UNII Code: TLM2976OFR

Setria

non-nutrient/non-botanical

Group: Glutathione

Also known as: reduced L-Glutathione, L-Glutathione

UNII Code: 0

Vitamin B2

vitamin

Group: Vitamin B2 (unspecified)

Vitamin B2, also known as Riboflavin, is a vital nutrient that belongs to the vitamin B complex. It plays a crucial role in energy production and the metabolism of fats, drugs, and steroids. Riboflavin is found in foods like eggs, green vegetables, milk, and meat, as well as in fortified foods and supplements.

Also known as: Riboflavin

Vitamin D3

vitamin

Group: Vitamin D

Vitamin D3, also known as cholecalciferol, is a fat-soluble vitamin that plays a crucial role in bone health by aiding in the absorption of calcium and phosphorus in the body. It can be produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Additionally, Vitamin D3 is found in dietary supplements and fortified foods to help maintain adequate levels for optimal health.

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Product Statements

General Statements: All Other Content

71905-0100-30

FDA Statement of Identity

Dietary Supplement

Formulation re: Other

Dispensed by prescription

Suggested/Recommended/Usage/Directions

Dosage and Administration: Usual adult dose is one (1) capsule once or twice daily or as prescribed by a licensed medical practitioner.

Precautions re: Children

Keep out of reach of children

Storage

Storage and Handling: Store as 20 degrees-25 degrees C (68 degrees-77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F) [See USP Controlled Room Temperature.] Protect from heat, light, and moisture

General Statements: All Other Content

For product information peel here

Precautions re: All Other

Health Claim Tobakient capsules dietary supplement dispensed by prescription This product is a prescription- folic acid with or without other dietary ingredients that – due to increased folic acid levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product.

Formulation re: Other

Tobakient is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients experiencing physiologically stressful conditions such as use of tobacco products, or to maintain levels when dietary intake of vitamins is inadequate or excretion or loss is excessive.

Precautions re: Allergies

Warning and Precautions: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: All Other

Tobakient capsules should only be used under the direction and supervision of a licensed medical practitioner.

Precautions re: Pregnant or Nursing or Prescription Medications

Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

Precautions re: Children

Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

General Statements: All Other Content

How Supplied Health Claims: Tobakient capsules are supplied as (blue and white, oblong-shaped) capsules in a child-resistant bottle of 30 count ("71905-0100-30").

General Statements: All Other Content

Levins Pharmaceuticals does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

Precautions re: Pregnant or Nursing or Prescription Medications

This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

General Statements: All Other Content

1. Federal Register Notice of August 2, 1973 (38 FR 20750) 2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3. Federal Register Notice of March 5, 1996 (61 FR 8760)

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Brand IP Statement(s) re: (c), (TM), (SM)

Setria is a registered trademark of KYOWA HAKKO CIO Co., Ltd. AstraReal is a trademark of Fuji Chemical Industry, Co., Ltd.

Precautions re: All Other

Tamper Evident: Do not use if seal is broken or missing. To report adverse events or to obtain product information, contact 228-392-0043.

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