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

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 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.

BOXED WARNING

(What is this?)

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.

DOSAGE AND ADMINISTRATION

One tablet daily, or as directed by a physician.

HOW 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.

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. There are no implied or explicit claims on therapeutic equivalence.

SPL UNCLASSIFIED SECTION

Reserved for Professional Recommendation.

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: 42937-706-10

PreNatal 19
Tablets

Vitamins and Minerals
with Folic Acid

Rx only

100 Tablets

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 42937-706
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 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
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	25 mg

Inactive Ingredients
Ingredient Name	Strength
Carnauba Wax (UNII: R12CBM0EIZ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Acacia (UNII: 5C5403N26O)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Stearic Acid (UNII: 4ELV7Z65AP)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	C41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42937-706-10	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)