FDA label e05ee6ce-0a9a-404c-aa77-43562bc7be17

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
1922c613-a8e2-4cf2-ab8b-bbc65c394309
SPL ID
e05ee6ce-0a9a-404c-aa77-43562bc7be17
Version
3
Effective date
2015-03-09
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:35

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. This package is intended for in-institution use only. Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Do not use in children under 6 years. Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs or if you need to use this product for pain for more than 10 days continuously (adults) or 5 days (children). Severe or recurrent pain, or high or continued fever may indicate a serious illness. If pregnant or breast-feeding, ask a health professional before use. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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