FDA label 582eb204-34c2-4de6-aba0-e43aa232184d

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
e3381145-ab3b-4f5a-8c45-9eadd53943a4
SPL ID
582eb204-34c2-4de6-aba0-e43aa232184d
Version
2
Effective date
2019-05-28
Source export date
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:30:47

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING: Accidental overdose of Iron-containing products is the leading cause of fatal poisoning of children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. Folic acid alone is improper therapy in the treatment for pernicious anemias and other megaloblastic anemias where Vitamin B 12 is deficient.

Adverse reactions cross-check#

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

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 PureFe OB Plus after meals may control occasional gastrointestinal disturbances. PureFe OB Plus is best absorbed when taken at bedtime. Call your doctor for medical advice about side effects. You may report suspected 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.