FDA label b50ddb37-e98d-428b-b1eb-58e53a8cf1e4

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
5e273c62-e582-4a40-90aa-c7c723cbcdf1
SPL ID
b50ddb37-e98d-428b-b1eb-58e53a8cf1e4
Version
2
Effective date
2017-09-20
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:58

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS: [PSYCHIATRY] Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. [ANTICONVULSANT] Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. [GENERAL] Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study. 7 Individuals taking nitrates for the treatment of angina may experience severe headaches when taking NAC/NAC derivatives. Carbamazepine levels may be reduced when NAC is used with that drug. 8 Patients at risk of developing renal stones, particularly cysteine stones, should avoid this product. Acetylcysteine clearance is reduced in preterm newborns as well as those with chronic liver disease. Do not administer to critically ill patients. Acetylcysteine and its sulfhydryl metabolites could produce a false-positive result in the nitroprusside test for ketone bodies used in diabetes. Acetylcysteine should be used with caution in those with a history of peptic ulcer disease since acetylcysteine may disrupt the gastric mucosal barrier. 9 [ONCOLOGY] Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.

warnings

Puralor ® Ci may also be administered by manually crushing a tablet, and then adding the contents to a thick juice or soft food - such as applesauce or yogurt. Puralor ® Ci may be chewed. Chewable tablets can be a choking hazard to those who cannot chew, such as elderly persons.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine. Call your medical practitioner about side effects. You may report side effects by calling (888) 886-2061.

Reported adverse events (FAERS/openFDA)#

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