FDA label 3ff25ebd-e44a-3bf3-e054-00144ff88e88

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
253bea06-aa5d-13bc-e054-00144ff88e88
SPL ID
3ff25ebd-e44a-3bf3-e054-00144ff88e88
Version
3
Effective date
2016-10-28
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:09

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only. Flammable, keep away from fire or flame. Do not use for eyes, around eye areas or on mucous membranes. In case of deep or puncture wounds, consult a doctor. Stop use if irritation or redness develops. If irritating condition persists for more than 72 hours, consult a physician. Keep out of reach of children . If swallowed, seek medical attention and/or contact a Poison Control Center immediately.

warnings

WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Patients with early Leber’s disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral Vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal ‘‘Gasping Syndrome’’ in premature infants.

Adverse reactions cross-check#

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Adverse reactions sections page 2 of 2 · 7 matching rows.

adverse reactions

Gastrointestinal Mild transient diarrhea.

adverse reactions

Dermatological Itching; transitory exanthema.

adverse reactions

Miscellaneous Feeling of swelling of entire body.

Reported adverse events (FAERS/openFDA)#

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