Ciferex Capsule

Manufacturer
Adler-Stern Pharmaceuticals, LLC
Effective date
2014-10-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:38

Label at a glance#

ProductCiferex
Active ingredientCHOLECALCIFEROL, FOLIC ACID
Label structure11 sections

Indications and uses

Ciferex is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.

Dosage and administration

Take one capsule daily or as directed by a physician.

Storage and handling

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088 . KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Ciferex is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation.

Ciferex should be administered under the supervision of a licensed medical practitioner.

Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula:

cifformcifform

Each capsule contains:
Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 3775IU

Each capsule contains the following inactive ingredients: Gelatin, cellulose, magnesium stearate, silica, FD&C Red #3, FD&C Yellow # 6.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Ciferex is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.

There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Ciferex is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

This medication is generally well tolerated. Notify your doctor if you experience: nausea, loss of appetite, vomiting, stomach cramps, dry mouth, increased thirst, increased urination, muscle or bone pain,headache, weakness, weight loss, dizziness. If you notice other effects not listed above, contact your doctor or pharmacist.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Take one capsule daily or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

Ciferex capsules are supplied as orange capsules printed with Ciferex dispensed in HDPE plastic bottles of 30ct.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

OTHER SAFETY INFORMATION

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only
Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:Adler-Stern Pharmaceuticals, LLC
Tampa, FL 33629
Rev. 10/14-3

CiferexlabelCiferexlabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69054-220-302020-01-31C16284748780-19d75b9d0-9172-f424-e053-dadaa90a57ceCiferex Capsule

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69054-220CIFEREX CAPSULE [ADLER-STERN PHARMACEUTICALS, LLC]1Unmatched20141111_7bc8730c-38cf-4bae-b8f2-da92751a551c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69054-220-30EA - Each69054-22040403fb6-6fd4-431b-aa06-e535775e2d7e12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
FOLIC ACIDACTIVE MOIETY935E97BOY81
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB61
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQY1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
GELATININACTIVE INGREDIENT2G86QN327L1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69054-22069054-220-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii candidate
34 equally ranked IID candidates
CELLULOSE ACETATECELLULOSE ACETATE3J2P07GVB6TABLET, CHEWABLE / ORAL27 mgExact identifier — unii candidate
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER / ORAL20 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / RECTAL0.5 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED / ORAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WCAPSULE / ORAL0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4bbebfa3-3a27-5a9b-e063-6294a90abee57bc8730c-38cf-4bae-b8f2-da92751a551c2026-02-26Warnings, Adverse reactionsExact identifier
spl set id: 7bc8730c-38cf-4bae-b8f2-da92751a551c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.