PR Natal 400 ec
PruGen, Inc Pharmaceuticals
PruGen, Inc. Pharmaceuticals
PR Natal 400 ec
FULL PRESCRIBING INFORMATION: CONTENTS*
- PR NATAL 400 EC DESCRIPTION:
- INDICATIONS:
- PR NATAL 400 EC CONTRAINDICATIONS:
- WARNINGS:PRECAUTIONS:
- WARNING:
- DRUG INTERACTIONS:
- PR NATAL 400 EC ADVERSE REACTIONS:
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED:
- STORAGE:DISPENSING:
- Box Label
FULL PRESCRIBING INFORMATION
DESCRIPTION:
PR Natal 400 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 400 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 400 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 400 ec (NDC 42546-517-30) 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 42546-517-30
PR Natal 400 ec
PR Natal 400 ecbeta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT
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