TOBAKIENT- ascorbic acid, cholecalciferol, riboflavin, pyridoxine hcl, folic acid, l-glutathione, astaxanthin capsule

Tobakient by

Drug Labeling and Warnings

Tobakient by is a Other medication manufactured, distributed, or labeled by Levins Pharmaceuticals, LLC, FORMULIFE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

STATEMENT OF IDENTITY

Tobakient™ 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 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.
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.

WARNINGS

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

PRECAUTIONS

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.

DOSAGE & ADMINISTRATION

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

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.

SAFE HANDLING WARNING

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.

INGREDIENTS AND APPEARANCE

TOBAKIENT 
ascorbic acid, cholecalciferol, riboflavin, pyridoxine hcl, folic acid, l-glutathione, astaxanthin capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71905-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	200 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	2 mg
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	250 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	20 ug
ASTAXANTHIN (UNII: 8XPW32PR7I) (ASTAXANTHIN - UNII:8XPW32PR7I)	ASTAXANTHIN	4 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1667 ug

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71905-100-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		03/04/2019

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
size (solid drugs)	21 mm
scoring	1
color
color
shape

Labeler - Levins Pharmaceuticals, LLC (080839485)

Registrant - Levins Pharmaceuticals, LLC (080839485)

Establishment
Name	Address	ID/FEI	Business Operations
FORMULIFE, INC.		024442806