Rx Only

DEXIFOL is a prescription multi-vitamin in the form of a dark yellow, film-coated, caplet.

DEXIFOL is a prescription multi-vitamin supplement that can be taken to improve nutritional status in conditions requiring dietary supplementation. DEXIFOL can also be used for the dietary management of individuals with distinct nutritional needs under a physician or healthcare provider's supervision for end stage failure, dialysis, hyperhomocysteinemia or inadequate dietary vitamin intake.

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

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

DO NOT EXCEED RECOMMENDED DOSAGE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in DEXIFOL Caplets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safer upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing DEXIFOL Caplets.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or healthcare provider before using or continuing use of this medication.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with the use of pyridoxine hydrochloride. Mild transient diarrhea, polycynthemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling of swelling of the entire body has been associated with the use of cyanocobalamin.

Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

Protect from light and moisture.
Dispense in a well-closed, tight, light-resistant container as defined by the USP using a child resistant closure.

DEXIFOL caplets are supplied as dark yellow, oblong, film coated caplets. DEXIFOL caplets are available in bottles of 30 (NDC: 70877-1002-01).

Distributed By:
Taleos Pharma Corp.
Eatontown, NJ 07724
www.taleos-pharma.com

70877-1002-1

DEXIFOL

PRESCRIPTION
MULTI-VITAMINS

WITH 100%
AbsoFol

Rx Only
30 CAPLETS

DIETARY SUPPLEMENT