FDA label 7d92e6d6-9678-486f-8550-a563b0052ee9

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
159633f5-702d-4792-822f-e88eef390c26
SPL ID
7d92e6d6-9678-486f-8550-a563b0052ee9
Version
4
Effective date
2017-10-17
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 02:33:01

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

WARNINGS AND PRECAUTIONS: SODIUM POLYSULTHIONATE AND FOLIC ACID should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that are pregnant, lactating, trying to conceive, under the age of 18, or taking medications. ADVERSE EVENTS: Mild gastrointestinal (GI) issues such as flatulence and nausea were observed in sodium polysulthionate patients. All GI incidences were categorized as “mild” and no patients discontinued due to adverse events. Allergic reactions have not been reported following the use of oral sodium polysulthionate. Sulfur, by itself, is not toxic to our bodies. However, some people are allergic to relatives of sulfur such as sulfites and sulfa drugs. Certain sulfites can trigger asthma and other allergic reactions in people who are sensitive. Tell your health care provider if you think you may be allergic to sulfur-containing substances. Folic acid, when administered in daily doses above 0.1mg, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for the treatment of a B12 deficiency. INTERACTIONS WITH DRUGS: Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. No decrease in effectiveness of drugs has been reported with the use of SODIUM POLYSULTHIONATE AND FOLIC ACID. Hydrogen sulfide may induce cytochrome P450 2B67 and 2E18, therefore it may decrease the half-life of medications metabolized by these enzymes. Careful monitoring of concomitant medications metabolized by these enzymes is recommended. ADVERSE REACTIONS: Mild gastrointestinal (GI) issues such as flatulence and nausea were observed in sodium polysulthionate patients. All GI incidences were categorized as mild and no patients discontinued due to adverse events. Allergic reactions have not been reported following the use of oral sodium polysulthionate. SODIUM POLYSULTHIONATE has been self-affirmed as Generally Recognized as Safe (GRAS). The highest level of sodium polysulthionate consumption has been 1,600MG per day in clinical studies although anecdotal reports of 3,000mg per day have used without adverse events.

Reported adverse events (FAERS/openFDA)#

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