FDA Label for Pr Natal 430 Ec
View Indications, Usage & Precautions
Pr Natal 430 Ec Product Label
The following document was submitted to the FDA by the labeler of this product Prugen, Inc Pharmaceuticals. 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.
Description:
PR Natal 430 ec is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules.
Indications:
PR Natal 430 ec is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. PR Natal 430 ec is also useful in improving nutritional status prior to conception.
Contraindications:
This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.
Warnings:Precautions:
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alphalinolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
Warning:
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.
Drug Interactions:
Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
Adverse Reactions:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration
Before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily, or as directed by a physician. The tablet and softgel capsule may be taken together or at different times of the day.
How Supplied:
A 30-day supply of PR Natal 430 ec (NDC 42546-518-30) is supplied in 2 bottles with child-resistant caps. One bottle contains 30 pink-brown oval tablets imprinted with ‘PE 669’ on one side. A second bottle contains 30 frosted golden-colored oval enteric-coated DHA softgel capsules.
Storage:Dispensing:
Store at controlled room temperature 20°-25°C (68°-77°F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations of the tablet.
Keep in a well-closed, light-resistant container. Supplied in a child-resistant bottle as a safeguard against ingestion by children. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Box Label
NDC 42546-518-30
PR Natal 430 ec
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