Tobakient Dailymed

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Statement Of Identity Section

Tobakientâ„¢ Capsules Dietary Supplement

Health Claim

Dispensed by Prescription†

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. ††

†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 B12deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigreereporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product.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. Theingredients, 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.

Warnings Section

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

Precautions Section

Tobakientâ„¢ 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.

Dosage & Administration Section

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

Tobakientâ„¢ 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.

Safe Handling Warning Section

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

KEEP OUT OF REACH OF CHILDREN

Tamper evident: Do not use if seal is broken or missing

To report adverse events or to obtain product information, contact 228-392-0043.