INDICATIONS AND USAGE: PreferaOB ONE® is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™) 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.
IMPORTANT SAFETY INFORMATION
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.
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
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.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information.
References
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ACOG (American College of Obstetrics and Gynecology) Practice Bulletin: nausea and vomiting of pregnancy. Obstet
Gynecol. 2004;103(4):803-814. 3. Hornstra G. Essential fatty acids in mothers and their neonates. Am J Clin Nutr.
2000;71(5)(suppl):1262S-1269S. 4. Hibbeln JR. Seafood consumption, the DHA content of mothers' milk and
prevalence rates of postpartum depression: a cross-national, ecological analysis. J Affect Disord. 2002;69(1-3):15-29.
5. How to get enough DHA in your diet. life'sDHA™ website. http://www.lifesdha.com/Pregnant-and-Nursing-Women/About-lifesDHA-.aspx. Accessed December 7, 2011. 6. McArdle HJ, Ashworth CJ. Micronutrients in fetal growth and
development. Br Med Bull. 1999;55(3):499-510. 7. US Department of Health and Human Services. Office on Women's
Health. Frequently asked questions: folic acid. http://www.womenshealth.gov/publications/our-publications/fact-sheet/folic-acid.pdf. Updated May 18, 2010. Accessed December 7, 2011. You'll need the Adobe® Acrobat® Reader in order to
view this document. You can download it for free here. 8. Honein MA, Paulozzi LJ, Mathews TJ, Erickson JD, Wong
LY. Impact of folic acid fortification of the US food supply on the occurrence of neural tube defects. JAMA.
2001;285(23):2981-2986. 9. Czeizel AE, Dudás I. Prevention of the first occurrence of neural-tube defects by
periconceptional vitamin supplementation. N Engl J Med. 1992;327(26):1832-1835. 10. PreferaOB ONE® [prescribing information]. Marietta, GA: Meda
Pharmaceuticals Inc; 2012.