ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol(R) Strips. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Vitafol(R) Strips is contraindicated in patients with hypersensitivity to any of its components or color additives.Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

DESCRIPTION SECTION.

COMPOSITION. Amount per daily dose (1 strip)VITAMINS AND MINERALS:Calories1Total Carbohydrates0 Sugars0 gVitamin B6 (as pyridoxine hydrochloride)2.5 mgFolic Acid1 mgVitamin B12 (as cyanocobalamin)12 mcgVitamin (as cholecalciferol)1000 IUOther Ingredients:Sentry Polyox WSR N80 LEO, maltitol syrup, methocel (hydroxypropyl methylcellulose), sodium citrate anhydrous, lemon flavor, sucralose, butylated hydroxytoluene, peceol, water.

DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS FOR USE. Before, during and after pregnancy, take one Vitafol(R) Strip daily, or as directed by physician.

DRUG INTERACTIONS SECTION.

DRUG INTERACTIONS. Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.Medications for hypertension used in conjunction with iodine supplementation may increase potassium.High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease patients response to methotrexate.Vitamin supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.Consult appropriate references for additional specific vitamin-drug interactions.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Vitafol(R) Strips is available as an orange rectangular film with V logo printed on one side. Available in Box of Unit-Dose pack in pouch of 30 counts, Item No. 0642-7468-30 and as physician sample in pouch of counts, Item No. 0642-7468-01.. Store at room temperature, approximately 20-25C (68-77F), avoid excessive heat, moisture and protect from light.To report suspected adverse event contact Exeltis USA, Inc., at 1-877-324-9349 or at FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS & USAGE SECTION.

USAGE. Vitafol(R) Strips provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and postnatal period for the lactating and non-lactating women.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 30 Strip Pouch Box. 0642-7468-30VITAFOLSTRIPSPrenatal Supplement Stripswith mg folic acidFast Dissolving StripUnit Dose Pack 30 StripsRx OnlyDIETARY SUPPLEMENT. PRINCIPAL DISPLAY PANEL 30 Strip Pouch Box.

PEDIATRIC USE SECTION.

Pediatric Use. Not for pediatric use.

SPL UNCLASSIFIED SECTION.

0642-7468-30Rx OnlyThese statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

STORAGE AND HANDLING SECTION.

Store at room temperature, approximately 20-25C (68-77F), avoid excessive heat, moisture and protect from light.To report suspected adverse event contact Exeltis USA, Inc., at 1-877-324-9349 or at FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

WARNINGS SECTION.

WARNINGS/PRECAUTIONS. This product is intended for use as directed by your healthcare provider. Please do not share with others.Vitamin supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.The use of folic acid doses above mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.Do not use if inner seal is broken or missing.Do not exceed recommended dose.Keep out of the reach of children.. DRUG INTERACTIONS. Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.Medications for hypertension used in conjunction with iodine supplementation may increase potassium.High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease patients response to methotrexate.Vitamin supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.Consult appropriate references for additional specific vitamin-drug interactions.. Information for Patients. Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.. Pediatric Use. Not for pediatric use.