FDA label 7164daaf-b77f-4bff-bb44-8b7623cf52c2

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: 195435f6-3c9b-4ac5-9502-859ef03c7523
SPL ID: 7164daaf-b77f-4bff-bb44-8b7623cf52c2
Version: 11
Effective date: 2010-12-29
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:48:27

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		7164daaf-b77f-4bff-bb44-8b7623cf52c2	id
spl set id		195435f6-3c9b-4ac5-9502-859ef03c7523	set_id

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

WARNINGS Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins.

Adverse reactions cross-check#

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

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

adverse reactions

ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

Reported adverse events (FAERS/openFDA)#

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