BENTIVITE (iron- as ferrous sulfate and folic tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)

Dostopno od:

Lifsa Drugs LLC

Pot uporabe:

ORAL

Terapevtske indikacije:

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.

Povzetek izdelek:

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)

Status dovoljenje:

Dietary Supplement

Lastnosti izdelka

BENTIVITE- IRON (AS FERROUS SULFATE) AND FOLIC TABLET
LIFSA DRUGS LLC
----------
BENTIVITE
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