O-CAL PRENATAL VITAMIN- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, iodine, magnesium, zinc, and copper tablet

O-Cal Prenatal Vitamin by

Drug Labeling and Warnings

O-Cal Prenatal Vitamin by is a Prescription medication manufactured, distributed, or labeled by Pharmics, Inc., NATIONAL VITAMIN CO., INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Supplement Facts Serving Size 1 Tablet
Amount Per Serving
Vitamin A (Beta Carotene)	2500 I.U.
Vitamin C (Ascorbic Acid)	70 mg
Vitamin D-3 (Cholecalciferol)	400 I.U.
Vitamin E (Acetate)	30 I.U.
Vitamin B-1 (Thiamine Monoitrate)	1.5 mg
Vitamin B-2 (Riboflavin)	1.6 mg
Niacin (Niacinamide)	17 mg
Vitamin B-6 (Pyridoxine HCI)	12 mg
Folic Acid	1 mg
Vitamin B-12 (Cyanocobalamin)	12 mcg
Calcium (Calcium Carbonate)	200 mg
Iron (Ferrous Fumarate)	15 mg
Iodine (Potassium Iodide)	150 mcg
Magnesium (Magnesium Oxide)	100 mg
Zinc (Zinc Oxide)	15 mg
Copper (Cupric Sulfate)	2 mg

Other Ingredients

Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Stearic Acid, Hydroxypropyl Methylcellulose, Titanium Dioxide, Triacetin, Silicon Dioxide.

Dosage

One tablet daily or as directed by a physician.

Indications

To provide vitamin and mineral supplementation prior to and through pregnancy and during the postnatal period, for both lactating and non-lactating mothers.

Caution

Folic Acid in doses above 1 mg may obscure pernicious anemia, in that hematological remission may occur while neurological manifestations remain progressive.

BOXED WARNING

(What is this?)

Additional 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.

SPL UNCLASSIFIED SECTION

1 800 456 4138
www.pharmics.com

Manufactured by
National Vitamin Co.
Casa Grande, AZ 85122

Distributed by
Pharmics Inc.
Salt Lake City, UT 84119

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC: 00813-0202-01

RX ONLY

HEALTHY
HAPPY

O-CAL PRENATAL

Vitamin & Mineral
Supplement with Folic Acid

Gluten Free

100 tablets

pharmics INC.

INGREDIENTS AND APPEARANCE

O-CAL PRENATAL VITAMIN 
vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, iodine, magnesium, zinc, and copper tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0813-0202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	70 mg
Cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE MONONITRATE	1.5 mg
Riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	Riboflavin	1.6 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	17 mg
Pyridoxine (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	Pyridoxine	12 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	Cyanocobalamin	12 ug
Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP)	Calcium	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS FUMARATE	15 mg
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	150 ug
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A)	Magnesium	100 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	15 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5)	Copper	2 mg

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
Magnesium Stearate (UNII: 70097M6I30)
Stearic Acid (UNII: 4ELV7Z65AP)
Hypromelloses (UNII: 3NXW29V3WO)
Titanium Dioxide (UNII: 15FIX9V2JP)
Triacetin (UNII: XHX3C3X673)
Sodium Peroxide (UNII: 3GSN3JCJ5K)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL (caplet)	Size	19mm
Flavor		Imprint Code	0813;PHARMICS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0813-0202-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/23/2002

Labeler - Pharmics, Inc. (058560996)

Establishment
Name	Address	ID/FEI	Business Operations
NATIONAL VITAMIN CO., INC		102098324	MANUFACTURE(0813-0202)