PR NATAL 430- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), P

Available from:

PruGen, Inc Pharmaceuticals

INN (International Name):

BETA CAROTENE

Composition:

BETA CAROTENE 3000 [iU]

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PR Natal 430 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 is also useful in improving nutritional status prior to conception. This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.

Product summary:

A 30-day supply of PR Natal 430 (NDC 42546-812-30) is supplied in 2 bottles with child-resistant caps. One bottle contains 30 pink-brown oval tablets imprinted with ‘B056’ on one side. A second bottle contains 30 translucent golden-colored oval DHA softgel capsules.

Authorization status:

unapproved drug other

Summary of Product characteristics

PR NATAL 430- BETA 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
PRUGEN, INC PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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PR NATAL 430
DESCRIPTION:
PR Natal 430 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 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 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 e