PreNatal 19

Manufacturer: Nationwide Laboratories, LLC
Effective date: 2020-03-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 23:39:27

Label at a glance#

ProductPreNatal 19

Active ingredientFOLIC ACID, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE

Label structure11 sections

Boxed 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.

Dosage and administration

One tablet daily or as directed by a physician.

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS:

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

INDICATIONS

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

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

WARNING

BOXED WARNING SECTION

PRECAUTIONS

PRECAUTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

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

PHARMACIST

SPL UNCLASSIFIED SECTION

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

STORAGE

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42937-707-10	2020-03-11	C162847	48780-1	9855e2a2-339c-60a7-e053-dbdaa90a05bd	PreNatal 19
42937-707-10	2019-11-27	C162847	48780-1	9855e2a2-339c-60a7-e053-dbdaa90a05bd	PreNatal 19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42937-707-10	EA - Each	42937-707	7b8436e7-17ae-4cdb-8a89-0a7953d7df0a	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
.ALPHA.-TOCOPHEROL ACETATE, DL-	ACTIVE INGREDIENT	WR1WPI7EW8	1
.BETA.-CAROTENE	ACTIVE INGREDIENT	01YAE03M7J	1
ASCORBIC ACID	ACTIVE INGREDIENT	PQ6CK8PD0R	1
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	1
CALCIUM PANTOTHENATE	ACTIVE INGREDIENT	568ET80C3D	1
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	1
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	1
FERROUS FUMARATE	ACTIVE INGREDIENT	R5L488RY0Q	1
FOLIC ACID	ACTIVE INGREDIENT	935E97BOY8	1
NIACINAMIDE	ACTIVE INGREDIENT	25X51I8RD4	1
PYRIDOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	68Y4CF58BV	1
RIBOFLAVIN	ACTIVE INGREDIENT	TLM2976OFR	1
THIAMINE MONONITRATE	ACTIVE INGREDIENT	8K0I04919X	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
.ALPHA.-TOCOPHEROL, DL-	ACTIVE MOIETY	7QWA1RIO01	1
.BETA.-CAROTENE	ACTIVE MOIETY	01YAE03M7J	1
ASCORBIC ACID	ACTIVE MOIETY	PQ6CK8PD0R	1
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	1
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	1
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	1
FERROUS CATION	ACTIVE MOIETY	GW89581OWR	1
FOLIC ACID	ACTIVE MOIETY	935E97BOY8	1
NIACINAMIDE	ACTIVE MOIETY	25X51I8RD4	1
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	1
RIBOFLAVIN	ACTIVE MOIETY	TLM2976OFR	1
THIAMINE ION	ACTIVE MOIETY	4ABT0J945J	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

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
FOLIC ACID
BETA CAROTENE
ASCORBIC ACID
CHOLECALCIFEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
.ALPHA.-TOCOPHEROL, DL-
THIAMINE MONONITRATE
THIAMINE ION
THIAMINE
RIBOFLAVIN
NIACINAMIDE
PYRIDOXINE HYDROCHLORIDE
PYRIDOXINE
CYANOCOBALAMIN
CALCIUM PANTOTHENATE
PANTOTHENIC ACID
CALCIUM CATION
CALCIUM CARBONATE
FERROUS FUMARATE
FERROUS CATION
ZINC OXIDE
ZINC CATION
magnesium stearate
maltodextrin
mannitol
silicon dioxide
stearic acid
sucralose
sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42937-707	42937-707-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FOLIC ACID	935E97BOY8	ACTIB
BETA CAROTENE	01YAE03M7J	ACTIB
ASCORBIC ACID	PQ6CK8PD0R	ACTIB
CHOLECALCIFEROL	1C6V77QF41	ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	ACTIM
THIAMINE MONONITRATE	8K0I04919X	ACTIR
RIBOFLAVIN	TLM2976OFR	ACTIB
NIACINAMIDE	25X51I8RD4	ACTIB
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	ACTIB
CYANOCOBALAMIN	P6YC3EG204	ACTIB
CALCIUM PANTOTHENATE	568ET80C3D	ACTIM
CALCIUM CARBONATE	H0G9379FGK	ACTIM
FERROUS FUMARATE	R5L488RY0Q	ACTIM
ZINC OXIDE	SOI2LOH54Z	ACTIM
magnesium stearate	70097M6I30	IACT
maltodextrin	7CVR7L4A2D	IACT
mannitol	3OWL53L36A	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
stearic acid	4ELV7Z65AP	IACT
sucralose	96K6UQ3ZD4	IACT
sucrose	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / TOPICAL	4 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING / DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 65 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SUSPENSION / OPHTHALMIC		9 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		164 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		658 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aee17618-5662-4f79-9d60-ace833c1e511			198442c8-730a-4635-a496-91e4767714a3	2021-12-20	Boxed warning, Warnings	Exact identifier spl set id: 198442c8-730a-4635-a496-91e4767714a3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.