FDA Label for Citranatal Medley
View Indications, Usage & Precautions
Citranatal Medley Product Label
The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Boxed Warning
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
Warnings
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 INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Description
CitraNatal Medley™ is a prescription prenatal/postnatal multi-vitamin/mineral soft gel with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and DHA, an essential fatty acid. The prenatal vitamin is an oval, purple, opaque soft gel containing a greenish-grey liquid to semi-solid fill. The prenatal soft gel is printed “896” in white ink.
Indications & Usage
CitraNatal Medley is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration
One prenatal soft gel daily or as directed by a physician.
How Supplied
Bottles of 30 soft gels each - NDC 00178-0896-30.
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