FDA label 65b898c8-9a29-4790-8444-741b6f1de0fc

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
1ac7a17e-75d0-4444-e054-00144ff88e88
SPL ID
65b898c8-9a29-4790-8444-741b6f1de0fc
Version
4
Effective date
2024-12-13
Source export date
2026-11-06
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:02:03

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Diabetics, patients prone to renal calculi, those undergoing stool occult blood tests and those on sodium restricted diets or anticoagulant therapy should not take excessive doses of ascorbic acid over an extended period of time.

warnings

PRESSURE MAY DEVELOP WITHIN THE VIAL UPON STORAGE. Exercise care when withdrawing and/or relieve pressure by first inserting sterile empty syringe into vial thus allowing pressure to equilibrate. When using dispensing vials use aseptic technique. Dispense entire contents in aliquots under a laminar flow hood without delay or within 4 hours after entry or discard remaining content after first withdrawal. Prepare stoppers with a suitable antiseptic solution. Do not use unless solution is clear and seal is intact. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Adverse reactions cross-check#

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

adverse reactions

Transient mild soreness may occur at the site of intramuscular or subcutaneous injection. Too-rapid intravenous administration of the solution may cause temporary faintness or dizziness.

Reported adverse events (FAERS/openFDA)#

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