Full Prescribing Information | U.S. Healthcare professionals
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
You can continue to read Important Safety Information at the bottom of this page
Considerations for using PreferaOB ONE®
There are certain circumstances under which PreferaOB ONE® should not be taken.
Who should not use PreferaOB ONE®
Patients with a known hypersensitivity to any of its ingredients.1
Adverse reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.1 To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
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.1
Warning (PreferaOB ONE®)
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.1
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.
Reference
1. PreferaOB ONE® [prescribing information]. Marietta, GA: Meda Pharmaceuticals Inc; 2012.