PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 30 SOFTGELS CARTON Rx Only NDC 0037-0086-30 PreferaOB ONE Pre/Post-natal Nutritional Supplement + DHA HEME Iron Non-HEME Iron 50 mg Vitamin B6 1 mg Folic Acid life'sDHA 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 1-877-999-8410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS & USAGE SECTION.


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

DOSAGE & ADMINISTRATION SECTION.


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

SPL UNCLASSIFIED SECTION.


Prenatal/Postnatal Multivitamin/Multimineral/ DHA softgel Rx Only

HOW SUPPLIED SECTION.


HOW SUPPLIED: PreferaOB ONE is supplied in child-resistant blister packs of 30 softgels (NDC 0037-0086-30). KEEP OUT OF REACH OF CHILDREN.

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 ONE is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (lifesDHA *). PreferaOB ONE is an oblong shaped, opaque purple colored softgel, imprinted "AP 86" in white ink on one side and plain on the other. Each PreferaOB ONE Softgel contains: VITAMINS MINERALS C (as ascorbic acid)..25 mg D3 (as cholecalciferol) ............................ 400 IU E (as dl-alpha tocopheryl acetate). 10 IU 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.28 mg (as PIC - polysaccharide iron complex) (as HIP - heme iron polypeptide as Proferrin**) Iodine (as potassium iodide)175 mcg Zinc (as zinc oxide) ................ 15 mg OMEGA-3 FATTY ACID Docosahexaenoic Acid (DHA)200 mg 200 mg of DHA from 500 mg of algal oil derived from Crypthecodinium cohnii. lifesDHA Oil includes: DHA algal oil, high oleic sunflower oil, ascorbyl palmitate (vitamin A) & tocopherols (as antioxidants). 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.

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. Distributed by: Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 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. 2015 Meda Pharmaceuticals Inc. IN-6886-05Rev 7/2015

INACTIVE INGREDIENT SECTION.


Other Ingredients: Gelatin, soybean oil, yellow beeswax, lecithin, D&C red #33, FD&C blue #1, titanium dioxide and purified water.

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.