FDA label 2e956093-0266-4a5a-8926-610a8ff7cdfd

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
05f405bb-6933-44a1-ab48-05faf19fbb4d
SPL ID
2e956093-0266-4a5a-8926-610a8ff7cdfd
Version
1
Effective date
2009-09-09
Source export date
2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:16

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings and cautions

Warnings and Precautions If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should be carefully re-evaluated because these could be signs of a serious condition. • Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. • To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

warnings and cautions

3. Warnings and Precautions 3.1 Colocynthis-Homaccord® Injection Solution exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects. 3.2 No harmful or potentially harmful side effects such as central nervous system depression are known. Colocynthis-Homaccord® Injection Solution is generally well-tolerated, however, if symptoms persist or worsen discontinue use. 3.3 Teratogenic effects: In general, homeopathic drugs are not known to cause direct or indirect harm to the fetus. Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. 3.4 Drug Interactions: None known 3.5 Drug / Laboratory Test Interaction: None known 3.6 Carcinogenesis, mutagenesis, impairment of fertility: Not applicable

Reported adverse events (FAERS/openFDA)#

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