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PR Natal 400 EC

Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement
Dosage Form: tablet

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.

PR Natal 400 EC

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 EC 
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 LABEL Item Code (Source) NDC:42546-517
Packaging
# Item Code Package Description
1 NDC:42546-517-30 1 KIT in 1 KIT
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 400 EC 
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- 3 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 PE669
Contains         
Packaging
# Item Code Package Description
1 30 TABLET in 1 BOTTLE
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 400 EC 
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 400 mg
Product Characteristics
Color brown Score no score
Shape capsule Size 19mm
Flavor Imprint Code none
Contains         
Packaging
# Item Code Package Description
1 30 CAPSULE, GELATIN COATED in 1 BOTTLE
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(42546-517)
Revised: 09/2012
 
PruGen, Inc Pharmaceuticals



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