PR Natal 430

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.

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 exceed 1 gram (1,000 mg) per day.

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 (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.

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 42546-812-30

PR Natal 430

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 kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-812

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42546-812-30 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 Part 2 1 BOTTLE 30

Part 1 of 2 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 tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 mg THIAMINE MONONITRATE (THIAMINE ION) THIAMINE ION 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN .012 mg CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg IRON PROTEIN SUCCINYLATE (IRON PROTEIN SUCCINYLATE) IRON PROTEIN SUCCINYLATE 7.25 mg FERROUS BISGLYCINATE HYDROCHLORIDE (IRON) IRON 21.75 mg MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg CUPRIC OXIDE (CUPRIC OXIDE) CUPRIC OXIDE 2 mg

Product Characteristics Color pink Score no score Shape capsule Size 19mm Flavor Imprint Code B056 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010

Part 2 of 2 PR NATAL 430 omega 3 fatty acids capsule, gelatin coated

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 430 mg

Inactive Ingredients Ingredient Name Strength GELATIN GLYCERIN

Product Characteristics Color brown Score no score Shape capsule Size 19mm Flavor Imprint Code none Contains

Packaging # Item Code Package Description Multilevel Packaging 1 30 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 01/01/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010

Labeler — PruGen, Inc Pharmaceuticals (929922750)

Registrant — PruGen, Inc. Pharmaceuticals (929922750)

Establishment
Name	Address	ID/FEI	Operations
National Vitamin Company		102098324	manufacture (42546-812)

Revised: 09/2012 PruGen, Inc Pharmaceuticals