Tobakientnone

Other Combinations

Brand: Levins Pharma

CapsuleOther CombinationsOff Market
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Net Contents

30 Capsule(s)

Serving Size

1 Capsule(s)

Servings Per Container

30

Supplement Form

Capsule

Bar Code (UPC/SKU)

3 71905 10030 1

Product Version

Rev. 01/19

Label Analysis

Objective insights generated automatically from the official DSLD label — a quick, factual read of how this product is formulated and disclosed.

7Active Ingredients

7 distinct active ingredients are disclosed in Supplement Facts.

100%Amount Transparency

Every active ingredient discloses a specific amount per serving.

5% Daily Value Coverage

5 ingredients report a %DV; 5 meet or exceed 100% DV.

This analysis is generated algorithmically from label data for educational reference only. It is not a product endorsement, ranking, or medical advice.

Supplement Facts

Serving Size: 1 Capsule(s) · 1–2 per day

IngredientAmount Per Serving% Daily Value
Vitamin C(Ascorbic Acid)200 mg222%
Vitamin D3(Cholecalciferol)20 mcg100%
Riboflavin(Vitamin B2)1.7 mg131%
Vitamin B6(Pyridoxine Hydrochloride)2 mg118%
Folic Acid1667 mcg DFE417%
Folic Acid1 mg—
L-Glutathione250 mg—
Astaxanthin(Haematococcus pluvialis Algae extract)4 mg—

Not Present

Other Ingredients

Microcrystalline CelluloseGelatinMagnesium StearateSilicaTitanium DioxideFD&C Blue 1

Target Groups

Adult (18 - 50 Years)

Label Claims

NutrientAll OtherStructure/Function

Directions & Suggested Use

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.

Warnings & Precautions

Precautions re: Children

Keep out of reach of children

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.

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.

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.

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.

Storage

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

Formulation

Formulation re: Other

Dispensed by prescription

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.

FDA Statements

FDA Statement of Identity

Dietary Supplement

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.

Other Label Statements

General Statements: All Other Content

71905-0100-30

General Statements: All Other Content

For product information peel here

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.

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)

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.

Manufacturer & Distributor

Distributor

Levins Pharmaceuticals, LLC

15121 Lemoyne Blvd, Biloxi, MS, 39532

228-392-0043

Market Reference

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Where to Buy Locally

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Research & Studies

  • Tagatose, the new GRAS sweetener and health product

    GV Levin - Journal of medicinal food, 2002 - journals.sagepub.com

    … and the potential health and medical benefits of this unique … foods, beverages, health foods, and dietary supplements. It fills … Various health and medical benefits are indicated, including …

    2002451 citations

Data sourced from the U.S. National Institutes of Health, Office of Dietary Supplements Dietary Supplement Label Database (DSLD) · Label entered 2020-03-24. DSLD Label ID: 214796. This information is provided for educational reference only and is not medical advice. Always follow the product label and consult a doctor or pharmacist before use.