FDA Label for O-cal Prenatal Vitamin
View Indications, Usage & Precautions
O-cal Prenatal Vitamin Product Label
The following document was submitted to the FDA by the labeler of this product Pharmics, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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| 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.
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.
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