| NDC | 0813-9616-01 |
| Set ID | 3b24458b-6d48-4cc6-8233-81f173277cb8 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Pharmics, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- 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.
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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 Acid 1 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.
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- Indications
- 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.
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There may be possible harmful effects of administering Folic Acid to patients who may have Pernicious Anemia (due to the possible masking of symptoms).
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1 800 456 4138
www.pharmics.comManufactured by
National Vitamin Co.
Casa Grande, AZ 85122Distributed by
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Pharmics Inc.
Salt Lake City, UT 84119 - PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
NDC 00813-9316-01
RX ONLY
HEALTHY
HAPPYO-CAL F.A.
Vitamin &
Mineral SupplementDye Free, Gluten Free, Sugar Free
with Fluoride and 1 mg Folic Acid100 tablets
pharmics INC.
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- INGREDIENTS AND APPEARANCE
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 tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0813-9616 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A 2500 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 90 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 3 mg Riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) Riboflavin 3 mg Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 20 mg Pyridoxine (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine 4 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) Cyanocobalamin 12 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 200 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 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 Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Magnesium Stearate (UNII: 70097M6I30) Stearic Acid (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Hypromelloses (UNII: 3NXW29V3WO) Triacetin (UNII: XHX3C3X673) Polydextrose (UNII: VH2XOU12IE) Product Characteristics Color BROWN Score no score Shape OVAL (caplet shape) Size 19mm Flavor Imprint Code 0813;PHARMICS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0813-9616-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/15/1970 Labeler - Pharmics, Inc. (058560996) CloseEstablishment Name Address ID/FEI Business Operations NATIONAL VITAMIN CO., INC 102098324 MANUFACTURE(0813-9616)