FDA label 0aacf4b2-45ad-beb2-e063-6394a90ae53c

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
4d4d823b-ff2f-4746-9bd7-44def2b81347
SPL ID
0aacf4b2-45ad-beb2-e063-6394a90ae53c
Version
4
Effective date
2024-01-31
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 06:36:00

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

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. Iron is toxic and has been shown to cause severe reactions in children including death.

warnings

Warning Folic acid alone is improper therapy in the treatment of pernicious anemia 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 REACTION Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving Centratex shortly after meals.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.