SPL UNCLASSIFIED SECTION.


Distributed by: Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 2015 Meda Pharmaceuticals Inc.70010893 U.S. Patent Nos. 7,585,527 and 8,080,520. *lifesDHA is a trademark of Martek Biosciences Corporation, Columbia, MD. **Proferrin is a registered trademark of Colorado BioLabs, Inc., Cozad, NE. IN-6883-04Rev. 7/2015

HOW SUPPLIED SECTION.


HOW SUPPLIED PreferaOB+DHA is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC 0037-0083-30). Each blister unit contains one tablet and one softgel. KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL - 30 TABLETS + 30 SOFTGELS CARTON Rx Only NDC 0037-0083-30 PreferaOB + DHA Pre/Post-natal Nutritional Supplement + DHA HEME Iron Non-HEME Iron 50 mg Vitamin B6 1 mg Folic Acid life'sDHA 30 Tablets + 30 Softgels

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 1-877-999-8409 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE PreferaOB+DHA is a prescription multivitamin/multimineral (PreferaOB ) and Omega-3 fatty acid (lifesDHA ) 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+DHA is also beneficial in improving the nutritional status of women prior to conception.

DOSAGE & ADMINISTRATION SECTION.


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

BOXED WARNING 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.

DESCRIPTION SECTION.


DESCRIPTION: PreferaOB + DHA is a prescription prenatal/postnatal multivitamin/multimineral (PreferaOB ) and Omega-3 fatty acid (life'sDHA ) nutritional supplement. PreferaOB + DHA 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 (PreferaOB ) and a clear essential fatty acid softgel containing an amber to light/dark orange semi-solid mixture (life'sDHA ). Each PreferaOB tablet contains: VITAMINS 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 MINERALS Iron..............................................34 mg (as PIP - 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). To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.

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). Each lifesDHA Softgel contains: Docosahexaenoic Acid (DHA).200 mg 200 mg of DHA from 500 mg of algal oil derived from Crypthecodinium cohnii Ingredients include: DHA algal oil, high oleic sunflower oil, ascorbyl palmitate (vitamin A) & tocopherols (as antioxidants) in a gelatin capsule (gelatin, glycerin, water, caramel color, carmine, calcium carbonate and turmeric). DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination.

CONTRAINDICATIONS SECTION.


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

WARNINGS SECTION.


WARNING 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 International Normalized Ratio (INR). Administration of Omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis.