Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12).

Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of pernicious anemia, it does not ameliorate the attendant neurologic involvement.

Resistance to treatment may be due to depressed hematopoiesis, alcoholism, the present of anti-metabolic drugs, and to deficiencies of vitamins.

Prolonged use of iron salts may produce iron storage disease.

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Folic acid (pteroylglutamic acid) and Vitamin B-12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both.

Folic acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances, allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Supplementation of the diet by milk or other dietary sources of Calcium may be advisable. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Allergic sensitivity reactions and gastrointestinal disturbances may occur.

VITAFOL^®-OB+DHA is available as a light blue, capsule shaped caplet imprinted "EV 0079" and one DHA Capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 caplets and 5 capsules each), NDC 0642-0076-30

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat.

U.S. Patent No. 6,814,983; 6,977,167; 5,407,957; 5,492,938 and other patents pending

Manufactured for
EVERETT LABORATORIES, INC.
West Orange, NJ 07052

Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Hydroxypropyl Methylcellulose, Titanium Dioxide, Polydextrose, Magnesium Stearate, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Triacetin, Dicalcium Phosphate, FD&C Blue #1 Aluminum Lake, Polyethylene Glycol, FD&C Blue #2 Aluminum Lake, D&C Yellow #10 Aluminum Lake.

Hydrocodone bitartrate is a potent antitussive which causes suppression of the cough reflex by a direct action on the cough center. Hydrocodone is approximately three times as potent as codeine on a weight basis, but has a higher addiction potential also. Phenylephrine hydrochloride is a sympathomimetic amine which acts predominantly on alpha receptors and has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation. Guaifenesin is an expectorant which exerts its action by stimulation of reflexes from the stomach and acts through the nauseant effect which increases the output from the secretory glands of the respiratory tract.

VITAFOL^®-OB+DHA: is indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception.

VITAFOL®-OB+DHA: Contains 1 mg folic acid, which is very important in the development of the baby's spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take folic acid supplementation.