FDA label d2b44ca8-95b7-4195-9095-eba392430481

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
b5bf9d12-6699-43ae-abc3-96b0bc7d822f
SPL ID
d2b44ca8-95b7-4195-9095-eba392430481
Version
3
Effective date
2012-06-15
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:38

Boxed warning cross-check#

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boxed warning

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.

Warnings cross-check#

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warnings

WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Not intended for treatment of pernicious anemia or other megaloblastic anemias where vitamin B 12 is deficient. Neurological involvement may develop or progress, despite temporary remission of anemia, in patients with vitamin B 12 deficiency who receive supplemental folic acid and who are inadequately treated with B 12 . Drug and Treatment Interactions As little as 5 mg pyridoxine daily can decrease the efficiency of levodopa in the treatment of parkinsonism. Therefore, Megavite Rx™ is not recommended for patients undergoing such therapy.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Megavite Rx™. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Reported adverse events (FAERS/openFDA)#

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