FDA label 2b03c3d4-74a3-418e-9dec-c367fa1effde

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
d0469b34-486f-451f-9319-48771df6857a
SPL ID
2b03c3d4-74a3-418e-9dec-c367fa1effde
Version
12
Effective date
2020-05-19
Source export date
2026-09-28
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/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:53

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 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. WARNINGS: For rectal use only Liver warning: This product contains acetaminophen. Severe liver damage may occur if -an adult or child 12 years or older takes more than 6 doses in 24 hours, which is the maximum daily amount -taken with other drugs containing acetaminophen -an adult takes 3 or more alcoholic drinks every day while using this product. Allergy Alert: acetaminophen may cause severe skin reactions. Symptoms may include: - skin reddening – blisters- rash – If a skin reaction occurs, stop use and seek medical help right away. Do not use -in children under 12 years -if you are allergic to acetaminophen -with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if -you have liver disease -if you are taking the blood thinning drug warfarin Stop use and ask a doctor if -fever lasts more than 3 days (72 hours), or recurs -pain gets worse or lasts more than 10 days -new symptoms occur -redness or swelling is present in the painful area -These may be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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