FDA label 0278a8ed-b74a-44ce-8d8b-e9cdf19b953b
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
- ad64bb83-5cd2-441b-b6c5-a830c718fb13
- SPL ID
- 0278a8ed-b74a-44ce-8d8b-e9cdf19b953b
- Version
- 2
- Effective date
- 2014-03-27
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:13:34
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 | 0278a8ed-b74a-44ce-8d8b-e9cdf19b953b | id | |
| spl set id | ad64bb83-5cd2-441b-b6c5-a830c718fb13 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNING: Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of 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. Prolonged use of iron salts may produce iron storage disease. Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or bleeding diathesis, individuals who have or suspected that they may have iron metabolism abnormalities should use caution in using supplemental iron. Iron supplementation in these individuals may lead to excess iron in the parenchyma of many organs. Iron storage and associated organ function tests may be indicated to ensure the delivery of needed iron to the neonate while ensuring the health of the mother.
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 gastrointestional disturbances may occur.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.