warnings
WARNINGS
FDA label 1b3003cf-478d-415e-b8ec-28001cf54405
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
- SPL set ID
- 1b3003cf-478d-415e-b8ec-28001cf54405
- SPL ID
- 1b3003cf-478d-415e-b8ec-28001cf54405
- Version
- 1
- Effective date
- 2011-03-10
- Source export date
- 2026-08-17
- 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/2026-08-17/c175bb03f5d8cc04ea33f7568ffa188cf4a6af159fe9da540d52ee57505d2752/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
- Import run
- 20260818T065550Z
- Imported at
- 2026-08-18 07:56:59
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 1b3003cf-478d-415e-b8ec-28001cf54405 | id | |
| spl set id | 1b3003cf-478d-415e-b8ec-28001cf54405 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine (Vitamin B6). Mild transient diarrhea, polycythemia vera, itching transient exanthema and feeling of swelling of entire body has been associated with cyanocobalamin (Vitamin B12). Oral supplementation with L-arginine at doses up to 15 grams daily are generally well tolerated. The most common adverse reactions of higher doses of arginine — from 15 to 30 grams daily — are nausea, abdominal cramps and diarrhea. Some may experience these symptoms at lower doses.