FDA.reportPublic FDA data

FDA label 91e1c467-3ded-15ff-e053-2995a90ae402

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
86947f1d-f2a2-2a28-e053-2991aa0a6727
SPL ID
91e1c467-3ded-15ff-e053-2995a90ae402
Version
3
Effective date
2019-09-06
Source export date
2026-08-08
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/1742e81476d3d6cada20c9e3894391dc6e407b1d0da716d0da13f6f74451bfd1/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:58:30

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For rectal use only Do not use for longer than one week unless directed by a doctor Ask a doctor before use if the child has abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks When using this product your child may have rectal discomfort or a burning sensation Stop use and ask a doctor if the child has rectal bleeding no bowel movement after using this product These may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.