Vitamin D label

Vitamin D

Vitamin D Recall

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Side Effects & Adverse Reactions

Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted.

Keep out of the reach of children.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

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History

There is currently no drug history available for this drug.

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Other Information

Ergocalciferol capsules, USP, is a synthetic calcium regulator for oral administration.

Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity.

There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity.

One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU.

Each capsule contains 1.25 mg (50,000 USP Units vitamin D) of ergocalciferol, USP, in an edible vegetable oil.

Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10 (19),22-tetraen-3-ol,(3β,5Z,7E,22E)-;(C28H44O) with a molecular weight of 396.65, and has the following structural formula:

Chemical structure

The soft gelatin capsule and imprinting ink contain: ammonium hydroxide, butyl alcohol, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol, propylene glycol, purified water, shellac glaze, simethicone, soybean oil, and titanium dioxide.

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Vitamin D Manufacturers

  • Preferred Pharmaceuticals, Inc.
    Vitamin D | Preferred Pharmaceuticals, Inc.
    No Recall

    Vitamin D | Preferred Pharmaceuticals, Inc.

    Vitamin D | Preferred Pharmaceuticals, Inc.

    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

    Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

    Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4g, six times per day.

    DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

    Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

  • Pd-rx Pharmaceuticals, Inc.
    Vitamin D | L.n.k. International, Inc.
    No Recall

    Vitamin D | L.n.k. International, Inc.

    Vitamin D | L.n.k. International, Inc.
    do not use more than directed drink a full glass of water with each dose adults and children 12 years and over take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor
  • Aphena Pharma Solutions – Tennessee, Llc
    Vitamin D | Aphena Pharma Solutions - Tennessee, Llc
    No Recall

    Vitamin D | Aphena Pharma Solutions - Tennessee, Llc

    Vitamin D | Aphena Pharma Solutions - Tennessee, Llc

    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

    Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

    Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4g, six times per day.

    DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

    Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

  • A-s Medication Solutions Llc
    Vitamin D | A-s Medication Solutions Llc
    No Recall

    Vitamin D | A-s Medication Solutions Llc

    Vitamin D | A-s Medication Solutions Llc

    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

    Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

    Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4g, six times per day.

    DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

    Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

  • Caraco Pharmaceutical Laboratories, Ltd.
    Vitamin D | Sun Pharmaceutical Industries, Inc.
    No Recall

    Vitamin D | Sun Pharmaceutical Industries, Inc.

    Vitamin D | Sun Pharmaceutical Industries, Inc.

    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

    Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

    Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4g, six times per day.

    DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

    Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

  • Paddock Laboratories, Llc
    Vitamin D | Paddock Laboratories, Llc
    No Recall

    Vitamin D | Paddock Laboratories, Llc

    Vitamin D | Paddock Laboratories, Llc

    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

    Vitamin D Resistant Rickets: 12,000 to 500,000 USP Units daily.

    Hypoparathyroidism: 50,000 to 200,000 USP Units daily concomitantly with calcium lactate 4 g, six times per day.

    DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

    Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary.

    X-rays of the bones should be taken every month until condition is corrected and stabilized.

  • Strides Arcolab Limited
    Vitamin D | Strides Arcolab Limited
    No Recall

    Vitamin D | Strides Arcolab Limited

    Vitamin D | Strides Arcolab Limited

    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

    Vitamin D Resistant Rickets: 12,000 to 500,000 USP Units daily.

    Hypoparathyroidism: 50,000 to 200,000 USP Units daily concomitantly with calcium lactate 4 g, six times per day.

    DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

    Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary.

    X-rays of the bones should be taken every month until condition is corrected and stabilized.

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