O-CAL F.A. Vitamin & Mineral Supplement

O-Cal FA multivitamin by

Drug Labeling and Warnings

O-Cal FA multivitamin 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]

O-CAL FA MULTIVITAMIN- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, iodine, magnesium, zinc, copper, and sodium fluoride 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.

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O-CAL F.A.
Vitamin &
Mineral Supplement

Supplement Facts
Serving Size 1 Tablet
Amount Per Serving
Vitamin A (Acetate)2500 I.U.
Vitamin C (Ascorbic Acid)90 mg
Vitamin D-3 (Cholecalciferol)400 I.U.
Vitamin E (Acetate)30 I.U.
Vitamin B-1 (Thiamine HCI)3 mg
Vitamin B-2 (Riboflavin)3 mg
Niacin (Niacinamide)20 mg
Vitamin B-6 (Pyridoxine HCI)4 mg
Folic Acid1 mg
Vitamin B-12 (Cyanocobalamin)12 mcg
Calcium (Carbonate)200 mg
Iron (Ferrous Fumarate)27 mg
Iodine (Potassium Iodide USP)150 mcg
Magnesium (Oxide)100 mg
Zinc (Zinc Oxide)15 mg
Copper (Cupric Sulfate)2 mg
Fluoride (as Sodium Fluoride)0.5 mg

Other Ingredients

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

Dosage

One tablet daily or as directed by a physician.

Indications

For vitamin and mineral supplementation.

Caution

Fluoride products should be used only in areas where drinking water content does not exceed recommended dosage. Excessive intake of fluoride may cause dental fluorosis.

Warning

There may be possible harmful effects of administering Folic Acid to patients who may have Pernicious Anemia (due to the possible masking of symptoms).

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: 00813-9316-01

RX ONLY

HEALTHY
HAPPY

O-CAL F.A.

Vitamin &
Mineral Supplement

Dye Free, Gluten Free, Sugar Free
with Fluoride and 1 mg Folic Acid

100 tablets

pharmics INC.

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
O-CAL FA MULTIVITAMIN 
vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, iodine, magnesium, zinc, copper, and sodium fluoride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0813-9616
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid90 mg
Cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) Cholecalciferol400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
Riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) Riboflavin3 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin20 mg
Pyridoxine (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine4 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) Cyanocobalamin12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine150 ug
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium100 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper2 mg
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Magnesium Stearate (UNII: 70097M6I30)  
Stearic Acid (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Triacetin (UNII: XHX3C3X673)  
Polydextrose (UNII: VH2XOU12IE)  
Product Characteristics
ColorBROWNScoreno score
ShapeOVAL (caplet shape) Size19mm
FlavorImprint Code 0813;PHARMICS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0813-9616-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/15/197005/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/15/197005/31/2019
Labeler - Pharmics, Inc. (058560996)

Revised: 11/2019
 
Pharmics, Inc.