warnings
WARNING Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the hematological profile or pernicious anemia, it does not ameliorate the underlying neurologic involvement.
FDA label 81215a6f-2b7e-4337-8895-cb3a6bbb215e
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
- 84caf591-915c-4575-9956-cc5c32a0873e
- SPL ID
- 81215a6f-2b7e-4337-8895-cb3a6bbb215e
- Version
- 11
- Effective date
- 2010-12-18
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:02:07
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 | 81215a6f-2b7e-4337-8895-cb3a6bbb215e | id | |
| spl set id | 84caf591-915c-4575-9956-cc5c32a0873e | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
WARNINGS AND PRECAUTIONS Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with RE Iron Tablets 90mg. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible. Folic Acid: Folic acid in doses above 1.0 mg daily may obscure pernicious anemia.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur with iron therapy. Folic Acid allergic sensitization has been reported following both oral and parenteral administration. Call your doctor for medical advice about side effects. You may report 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.