O-cal Prenatal Vitamin
FDA Label NDC 0813-0202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmics, Inc. for the product O-cal Prenatal Vitamin (NDC 0813-0202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, other ingredients, dosage, indications, caution, additional warning, principal display panel - 100 tablet bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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 Acid1 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.

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)

Principal Display Panel (100 Tablet Bottle Label)

* Please review the disclaimer below.