FDA label cefaa207-18ff-fc64-e053-2a95a90acc95

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
adce9efb-0a39-80ec-e053-2995a90a53bb
SPL ID
cefaa207-18ff-fc64-e053-2a95a90acc95
Version
2
Effective date
2021-10-22
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:32:11

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Vitamin D therapy should be cautiously used in patients with hyperparathyroidism (or any condition which may lead directly or indirectly to hypercalcemia), hypercalcemia, or people who have renal stones or at risk of having renal stones. High doses of vitamin D may elevate levels of calcium, which may eventually accumulate in the blood and soft tissues. Bone pain, high blood pressure, the formation of kidney stones, renal failure, and increased risk of heart disease can also occur. Prolonged use of iron supplements may lead to iron storage disease. WARNING: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. High Dose Folic acid supplementation may conceal an occult vitamin B 12 deficiency and further exacerbate or initiate neurologic disease. Therefore, clinicians should consider ruling out vitamin B 12 deficiency before initiating folic acid therapy. Do NOT use Abavite if you have an allergy for one or more components listed above. Possible interactions: High doses of folic acid may result in reduced serum levels of anticonvulsant drugs. Vitamin D supplementation should be avoided in hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones (Calcium oxalate stones). Consult your physician or pharmacist for additional information regarding vitamin-drug interactions.

Reported adverse events (FAERS/openFDA)#

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