Bentivite: Package Insert and Label Information

BENTIVITE- ferrous sulfate and folic acid tablet
Lifsa Drugs LLC

HEALTH CLAIM:

Bentivite Tablets — Dietary Supplement

Dispensed by Prescription

Supplement Facts
Serving Size: 1 Tablet
Serving per Bottle: 30
Amount Per Serving: % Daily Value
Iron (as ferrous sulfate) 35 mg 194%
Folic Acid 1 mg 417%

OTHER INGREDIENTS: Microcrystalline Cellulose, Dicalcium Phosphate Unmilled (Di-Tab), Stearic Acid, Croscarmellose Sodium, Magnesium Stearate and Silicon Dioxide.

DESCRIPTION:

Bentivite Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

CONTRAINDICATIONS:
Bentivite Tablets are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNING:

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

Bentivite tablets 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.

Pregnancy and Lactation
Bentivite is not intended for use in pregnant or lactating patients.

PRECAUTION:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Bentivite Tablets should only be used under the direction and supervision of a licensed medical practitioner.

Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicine and vitamins with iron be packaged in child-resistant closures. Parents should always use properly re-secure safety closures.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling the FDA at 1-800-FDA-1088.

DOSAGE & ADMINISTRATION:

Usual adult dose is 1 tablet taken orally once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

Bentivite Tablets are available as white, round tablets and are available in 30-count bottles (72336-014-01*). This product is not an Orange Book product.

Dispensed by Prescription

Manufactured for: Lifsa Drugs LLC, New Brunswick, NJ 08901

Rev. 08/21

*Lifsa Drugs LLC 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 is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. 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)

STORAGE AND HANDLING:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture. Tamper Evident: Do not use if seal is broken or missing.

Distributed by: Lifsa Drugs LLC, NJ 08901

PACKAGE LABEL:

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BENTIVITE
iron (as ferrous sulfate) and folic tablet
Product Information
Product Type Item Code (Source) NDC:72336-014
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION 35 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
STEARIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72336-014-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 10/05/2021
Labeler — Lifsa Drugs LLC (081205160)

Revised: 10/2021 Lifsa Drugs LLC

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