Tobakient

71905-0100-30

Dietary Supplement

Dispensed by prescription

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

Keep out of reach of children

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

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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.

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.

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

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

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.

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.

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").

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.

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.

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)

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.

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

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