FDA label fb38f0e4-dd21-41dd-8da5-1d469068834e

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
fd53ae91-8f84-4a39-8680-130152ac0b16
SPL ID
fb38f0e4-dd21-41dd-8da5-1d469068834e
Version
2
Effective date
2016-01-13
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:23

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

WARNINGS AND PRECAUTIONS GENERAL: 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. Sulfa drugs can cause hypoglycemia (low blood sugar), skin rashes, high fever, headache, fatigue, and gastric problems for people with alpha drug allergies. 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). 5-methyltetrahydrofolate may be less likely than folic acid to mask vitamin B12 deficiency. 9-10 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 XIZFLUS. 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. 1 All GI incidences were categorized as mild and no patients discontinued due to adverse events 1 . Allergic reactions have not been reported following the use of oral sodium polysulthionate. USE IN SPECIFIC POPULATIONS: Pregnancy : XIZFLUS has not been studied in pregnant women. The choice to administer SULFZIX during pregnancy is at the clinical discretion of the prescribing physician. Labor and Delivery/NursingMothers : XIZFLUS has not been studied in labor and delivery. The choice to administer XIZFLUS during labor and delivery is at the clinical discretion of the prescribing physician. Overdosage : No specific information is available on the treatment of overdosage with XIZFLUS. XIZFLUS 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.