Full Prescribing Information for PreferaOB® products

 

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Description
Overview of PreferaOB ONE®, including a description of how it appears.

Vitamins
List of vitamins, including dosages, in PreferaOB ONE® softgel prenatal vitamins.

Minerals
List of minerals, including dosages, in PreferaOB ONE® softgel prenatal vitamins.

Omega-3 fatty acid
Dosage of the docosahexaenoic acid (DHA) that's in PreferaOB ONE® as well as a list of accompanying ingredients and a description of its derivation.

Other ingredients
List of other ingredients in PreferaOB ONE® prenatal vitamins.

Indications and usage
Indications and usage for PreferaOB ONE®.

Contraindications
Description of patients for whom PreferaOB ONE® is contraindicated.

Warnings
Important warnings for patients who use PreferaOB ONE®.

Precautions
Important considerations for patients taking PreferaOB ONE®.

Adverse reactions
Notification that allergic sensitization has been reported to a key ingredient of PreferaOB ONE®.

Dosage and administration
Instructions for taking PreferaOB ONE®.

How supplied
Description of how PreferaOB ONE® is supplied.

Storage
Instructions for storing PreferaOB ONE®.

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.