O-Cal Prenatal Vitamin

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
Pharmics, Inc.

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.

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.

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.

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.

PRINCIPAL DISPLAY PANEL -- 100 Tablet Bottle Label
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 2500 [iU]
Ascorbic Acid (ascorbic acid) Ascorbic Acid 70 mg
Cholecalciferol (CHOLECALCIFEROL) Cholecalciferol 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 1.5 mg
Riboflavin (RIBOFLAVIN) Riboflavin 1.6 mg
Niacin (Niacin) Niacin 17 mg
Pyridoxine (PYRIDOXINE) Pyridoxine 12 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (CYANOCOBALAMIN) Cyanocobalamin 12 ug
Calcium (Calcium) Calcium 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS FUMARATE 15 mg
Iodine (Iodine) Iodine 150 ug
Magnesium (Magnesium) Magnesium 100 mg
Zinc (Zinc) Zinc 15 mg
Copper (Copper) Copper 2 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
CROSCARMELLOSE SODIUM
Magnesium Stearate
Stearic Acid
Hypromelloses
Titanium Dioxide
Triacetin
Sodium Peroxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (caplet) Size 19mm
Flavor Imprint Code 0813;PHARMICS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0813-0202-01 100 TABLET in 1 BOTTLE None
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 Operations
NATIONAL VITAMIN CO., INC 102098324 MANUFACTURE (0813-0202)

Revised: 09/2012 Pharmics, Inc.

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