AV-VITE FB FORTE - pyridoxine hydrochloride, folic acid, and cyanocobalamin tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

AvKARE, Inc.

INN (International Name):

PYRIDOXINE HYDROCHLORIDE

Composition:

PYRIDOXINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Authorization status:

Dietary Supplement

Summary of Product characteristics

AV-VITE FB FORTE - PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, AND
CYANOCOBALAMIN TABLET, COATED
AVKARE, INC.
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AV-VITE FB FORTE
PRESCRIPTION DIETARY SUPPLEMENT
DESCRIPTION: Av-VITE FB Forte Tablets are an orally administered
prescription dietary
supplement for the management of patients requiring increased folate
levels.
Av-VITE FB Forte Tablets should be administered under the supervision
of a licensed medical
practitioner.
SUPPLEMENT FACTS
SERVING SIZE: 1 TABLET
AMOUNT
PER
SERVING
% DAILY
VALUE
VITAMIN B (as Pyridoxine HCl)
25 mg
1250%
FOLIC ACID
2.5 mg
625%
VITAMIN B
(as Cyanocobalamin)
2 mg
33333%
OTHER INGREDIENTS: Dibasic Calcium Phosphate Dihydrate,
Microcrystalline Cellulose, Opadry II
Beige 40L17427 (Titanium Dioxide, Polydextrose, Hypromellose 3cP,
Hypromellose 6cP, Triacetin,
Hypromellose 50cP, Polyethylene Glycol 8000, FD&C Yellow # 6 Aluminum
Lake, FD&C Blue # 2
Aluminum Lake, FD&C Red #40 Aluminum Lake), Croscarmellose Sodium,
Opadry II Clear #Y-19-
7483 (Hypromellose 6cP, Maltodextrin, Hypromellose 3cP, Polyethylene
Glycol 400, Hypromellose
50cP) Magnesium Stearate.
Contains: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake,
FD&C Red #40
Aluminum Lake
ALLERGY STATEMENT: This product has been manufactured in a facility
that also manufactures
products containing milk and soy. Individuals with allergic tendencies
to these substances should use
discretion.
Allergic reactions have been reported following the use of oral
folate.
Mild transient diarrhea, polycythemia vera, itching, transitory
exanthema and the feeling of swelling of
the entire body have been associated with cobalamin.
Paresthesia, somnolence, nausea, and headaches have been reported with
pyridoxine.
CONTRAINDICATIONS: This product is contraindicated in patients with a
known hypersensitivity to
any of the components contained in this product.
CAUTION: High levels of folic acid may, especially in older adults,
hide signs of vitamin B-12
deficiency (such as pernicious anemia), a condition that can cause
nerve damage.
INTERACTIONS