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PreNatal 19

Generic Name: oil soluble vitamins, water-soluble vitamins and minerals
Dosage Form: tablet, coated

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.

PreNatal 19

PreNatal 19 Description

PreNatal 19 provides oil soluble vitamins, water-soluble vitamins and minerals.

Each tablet contains:
Vitamin A (as beta carotene) 1000 IU
Vitamin C (ascorbic acid) 100 mg
Vitamin D (as cholecalciferol) 400 IU
Vitamin E (as dl-alpha-tocopheryl acetate) 30 IU
Thiamine Mononitrate (Vitamin B1) 3 mg
Riboflavin (Vitamin B2) 3 mg
Niacin (as niacinamide) 15 mg
Vitamin B6 (as pyridoxine HCl) 20 mg
Folate (folic acid) 1 mg
Vitamin B12 (as cyanocobalamin) 12 mcg
Pantothenic Acid
(as calcium pantothenate) 7 mg
Calcium (as calcium carbonate) 200 mg
Iron (as ferrous fumarate) 29 mg
Zinc (as zinc oxide) 20 mg
Docusate Sodium 25 mg

OTHER INGREDIENTS

Carnauba Wax, Fumed Silica, Gum Arabic, Hydroxy Propyl Methyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Talc, and Titanium Dioxide.

INDICATIONS

PreNatal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreNatal 19 tablets are also useful in improving the nutritional status of women prior to conception.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

PreNatal 19 Dosage and Administration

One tablet daily, or as directed by a physician.

How is PreNatal 19 Supplied

PreNatal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "C41," packaged in bottles of 100 tablets.

NDC 42937-706-10.

STORAGE

Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.

PHARMACIST

Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

Reserved for Professional Recommendation.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Distributed by:
Nationwide Laboratories LLC
Iselin NJ 08830

Lot No.: Exp. Date: Rev. 12/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Nationwide Laboratories LLC

NDC 42937-706-10

PreNatal 19
Tablets

Vitamins and Minerals
with Folic Acid

Rx only

100 Tablets

PreNatal 19 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide, and docusate sodium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42937-706
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 1000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID and CALCIUM CATION) PANTOTHENIC ACID 7 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 20 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax  
silicon dioxide  
acacia  
hypromelloses  
Magnesium Stearate  
Cellulose, Microcrystalline  
Polyethylene Glycols  
Stearic Acid  
Talc  
Titanium Dioxide  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code C41
Contains         
Packaging
# Item Code Package Description
1 NDC:42937-706-10 100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/01/2013
Labeler - Nationwide Laboratories, LLC (078366153)
Revised: 02/2014
 
Nationwide Laboratories, LLC



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