FDA label 96dda94d-7cc5-42ea-9401-455c5df7cb08

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: ae9a32ca-f012-40ca-aae2-dee40758f903
SPL ID: 96dda94d-7cc5-42ea-9401-455c5df7cb08
Version: 3
Effective date: 2009-12-10
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:58:46

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		96dda94d-7cc5-42ea-9401-455c5df7cb08	id
spl set id		ae9a32ca-f012-40ca-aae2-dee40758f903	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: Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Adverse reactions cross-check#

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

adverse reactions

Adverse Reactions: Allergic sensitization has been reported rarely following oral and parenteral administration of Folic Acid. Nicotinamide ZCF is expected to be well tolerated at recommended doses. At doses greater than the recommended dose gastrointestinal distress such as nausea or vomiting have been associated with the administration of nicotinamide or zinc. Nicotinamide: Dizziness, headache, hyperglycemia, nausea, vomiting, diarrhea, elevations in liver function tests, hepatotoxicity, blurred vision, flushing, rash. Store between 15°-30°C (59°-86°F). Manufactured for: River's Edge Pharmaceuticals, LLC. Suwanee, GA 30024 Rev. 07/08 344-11

Reported adverse events (FAERS/openFDA)#

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