FOLBIC- pyridoxine and cyanocobalamin and folic acid tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

PYRIDOXINE

Composition:

PYRIDOXINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Folbic Tablets are indicated for the distrinct nutritional requirements of individuals under a physician's supervision for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atheroscierotic vascular disease in the coronary, peripheral, or cerebral vessels, or vitamin B12 dificiency. Known hypersensitivity to any of the components in the product is a contraindication.

Product summary:

Folbic Tablets are available as an oval, rose colored tablet, debossed B 384. Supplied in blisterpacks of 30 tablets, NDC# 0615-7575-39. Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF.

Authorization status:

unapproved drug other

Summary of Product characteristics

FOLBIC- PYRIDOXINE AND CYANOCOBALAMIN AND FOLIC ACID TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FOLBIC TABLET
DESCRIPTION
Each rose colored tablet contains the following active ingredients:
Folacin (Folic Acid) 2.5 mg,
Pyridoxine (B6) 25mg, Cyanocobalamin (B12) 2mg, Folbic Tablets do not
contain sugar or lactose.
Inactive Ingredients: Carmine, Croscarmellose Sodium, Dicalcium
Phosphate, Hypromellose,
Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose,
Mineral Oil, Riboflavin, Sodium
Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.
INDICATIONS AND USAGE
Folbic Tablets are indicated for the distrinct nutritional
requirements of individuals under a physician's
supervision for hyperhomocysteinemia; with particular emphasis for
individuals with or at risk for
atheroscierotic vascular disease in the coronary, peripheral, or
cerebral vessels, or vitamin B12
dificiency.
CONTRAINDICATIONS
Known hypersensitivity to any of the components in the product is a
contraindication.
WARNINGS
KEEP THIS AND ALL MEDICATIO OUT OF THE REACH OF CHILDREN IN CASE OF
ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON
CONTROL CENTER IMMEDIATELY.
All prescription substitutions using this product ahall be pursuant ot
state statutes as applicable. This is
not an Orange Book Product.
PRECAUTIONS
GENERAL
Folacin (folic acid) when administered as a single agent in doses
above 0.1 mg daily may obscure
pemicious anemia in that hematologic remission can occur while
neurological manifestations remain
progressive. The 2mgs of cyanocobalamin contained in Folbic Tablets
has been shown to provide an
adequate amount of cyanocobalamin to address this precaution.
Unmetabolized folic acid has been
shown in one study of 105 postmenopausal women (50-75 yrs) to have the
potential to reduce natural
killer cells' cyt