INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE: PreferaOB is a prescription multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreferaOB is also beneficial in improving the nutritional status of women prior to conception.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION: One tablet daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

SPL UNCLASSIFIED SECTION.


Distributed by: MEDA Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 2015 Meda Pharmaceuticals Inc. U.S. Patent Nos. 7,585,527 and 8,080,520. Proferrin is a registered trademark of Colorado BioLabs, Inc., Cozad, NE. IN-6884-04 Rev 7/2015

HOW SUPPLIED SECTION.


HOW SUPPLIED: PreferaOB is supplied in a child-resistant bottle of 90 tablets (NDC 0037-0084-90). KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 90 TABLETS LABEL NDC 0037-0084-90 PreferaOB Distributed by: MEDA Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 US Patent Nos. 7,585,527 and 8,080,502 2015 Meda Pharmaceuticals Inc. Rx Only 90 Tablets

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8408 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION SECTION.


DESCRIPTION: PreferaOB is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement. PreferaOB is a small, oval, film-coated, purple tablet with black core, debossed and bisected with "AP/84" on one side, and plain on the other. Each PreferaOB tablet contains: VITAMINS MINERALS D3 (as cholecalciferol) .........................400 IU E (as d-alpha tocopheryl acid succinate) 10 IU B1 (as thiamine mononitrate) ................1.5 mg B2 (as riboflavin)..................................1.6 mg B3 (niacin as niacinamide)......................17 mg B6 (as pyridoxine HCl) .........................50 mg Folic Acid ..............................................1 mg B12 (as cyanocobalamin) .....................12 mcg Biotin ................................................. 30 mcg B5 (as d-calcium pantothenate)...............10 mg Iron...34 mg (as PIC - polysaccharide iron complex) (as HIP - heme iron polypeptide as Proferrin*) Iodine (as potassium iodide) 250 mcg Zinc (as zinc oxide) ................ 4.5 mg Selenium (as sodium selenate) 65 mcg Copper (as cupric sulfate)....... 0.8 mg

PRECAUTIONS SECTION.


PRECAUTIONS: Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

STORAGE AND HANDLING SECTION.


STORAGE: Store at controlled room temperature 20-25C (68-77F). Excursions permitted to 15-30C (59-86F). Dispense in a tight, light-resistant container to protect from light and moisture.

INACTIVE INGREDIENT SECTION.


Other Ingredients: Microcrystalline cellulose, croscarmellose sodium, crospovidone, silicon dioxide, magnesium stearate (vegetable source), modified food starch, dibasic calcium phosphate, resin, sucrose, ethylcellulose, sodium ascorbate, medium chain triglycerides, dl-alpha tocopherol, coating (polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake).

CONTRAINDICATIONS SECTION.


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

WARNINGS SECTION.


WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.