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
二酸化ケイ素
—
—
—
その他
葉酸
—
1,667μg DFE
417%
主成分
酸化チタン
—
—
—
その他
葉酸
—
1mg
—
主成分
FD&C Blue 1
—
—
—
その他
L-Glutathione
—
250mg
—
主成分
アスタキサンチン
Haematococcus pluvialis Algae extract
4mg
—
主成分
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)
Levins Pharma Tobakient | Supplement DB
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.