PRENATAL 19- folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, and zinc oxide tablet, chewable

PreNatal 19 by

Drug Labeling and Warnings

PreNatal 19 by is a Prescription medication manufactured, distributed, or labeled by Nationwide Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

PreNatal 19 chewable tablets are round, debossed "C43". These tablets provide oil-soluble vitamins and minerals.

Each tablet has the following active ingredient:
Folate (folic acid)	1 mg
Each tablet also contains the following ingredients for nutritional supplement:
Vitamin A (as beta carotene)	1000 IU
Vitamin C (as ascorbic acid)	100 mg
Vitamin D (as cholecalciferol)	400 IU
Vitamin E (as dl-alpha-tocopheryl acetate)	30 IU
Thiamine (Vitamin B1)
(thiamine mononitrate)	3 mg
Riboflavin (Vitamin B2)	3 mg
Niacin (as niacinamide)	15 mg
Vitamin B6 (as pyridoxine HCl)	20 mg
Vitamin B12 (as cyanocobalamine)	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

OTHER INGREDIENTS:

Flavors, magnesium stearate, maltodextrin, mannitol, silicon dioxide, stearic acid, sucralose and sucrose.

INDICATIONS

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

BOXED WARNING

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WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the 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 hematological remission can occur while neurological manifestations remain progressive.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

PreNatal 19 chewable tablets for oral administration are supplied as multi-color-speckled,round tablets debossed "C43", packaged in bottles of 100 tablets.

PHARMACIST

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

STORAGE

Store at 20°-25°C (68°-77°F) [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.

SPL UNCLASSIFIED SECTION

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.

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

SPL UNCLASSIFIED SECTION

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: 42937-707-10

PreNatal 19
Chewable Tablets

A Prescription Prenatal Vitamin
with other Vitamins and Minerals
for Nutritional Supplementation

Rx only

100 Tablets

INGREDIENTS AND APPEARANCE

PRENATAL 19 
folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, and zinc oxide tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42937-707
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	1000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	15 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	20 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB)	PANTOTHENIC ACID	7 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 mg

Inactive Ingredients
Ingredient Name	Strength
magnesium stearate (UNII: 70097M6I30)
maltodextrin (UNII: 7CVR7L4A2D)
mannitol (UNII: 3OWL53L36A)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
sucralose (UNII: 96K6UQ3ZD4)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	BROWN (multi-color-speckled)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	C43
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42937-707-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2013

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)