FDA label 37359587-129b-461f-a82f-b4461eeff080

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
8896031e-7cb4-4376-84b1-97eae5015ec4
SPL ID
37359587-129b-461f-a82f-b4461eeff080
Version
1
Effective date
2011-11-28
Source export date
2026-08-17
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/40383c0781ea3f73e5df32231f8b65ed8ddb390c4f71cf8c3047378d0f083484/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:05:53

Boxed warning cross-check#

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boxed warning

Boxed Warning WARNING: 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 a Poison Control Center immediately.

Warnings cross-check#

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warnings and cautions

WARNINGS/PRECAUTIONS: Reaphirm Plant Source DHA should be used with caution in patients with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kigney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Iodine should be used with caution in patients with an overactive thyroid. Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage. Keep out of the reach of children. Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions. Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. Pediatric Use: Not for pediatric use. Adverse Reactions Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Reaphirm Plant Source DHA. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Adverse reactions cross-check#

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adverse reactions

Adverse Reactions Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Reaphirm Plant Source DHA. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.