FDA label 2f0c3858-5acc-4974-9be7-71ecdaecbcf2

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
17e7d7d8-d27c-4888-84b9-45305df62066
SPL ID
2f0c3858-5acc-4974-9be7-71ecdaecbcf2
Version
4
Effective date
2020-01-18
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:23:17

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Avoid the intravenous route. Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B 12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Blunted or impeded therapeutic response to vitamin B 12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis. A few patients may experience pain after injection of hydroxocobalamin. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Reported adverse events (FAERS/openFDA)#

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