FDA label 347bfebd-f3c4-441d-a41c-86e5908dfff8
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
- 9b15b867-36a9-4896-9ecf-94de607bf50d
- SPL ID
- 347bfebd-f3c4-441d-a41c-86e5908dfff8
- Version
- 3
- Effective date
- 2019-02-07
- Source export date
- 2026-10-12
- 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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:32:30
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 | 347bfebd-f3c4-441d-a41c-86e5908dfff8 | id | |
| spl set id | 9b15b867-36a9-4896-9ecf-94de607bf50d | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. ␣␣ WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. ␣␣ PRECAUTIONS: General: Folic acid in doses above 0.1 mg -0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Tandem® DHA after meals may control occasional G.I. disturbances. Tandem® DHA is best absorbed when taken at bedtime.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.