FDA label 28655b75-0302-94a1-e063-6394a90ae1dc

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
c5b3c78c-9148-bf69-e053-2995a90aba65
SPL ID
28655b75-0302-94a1-e063-6394a90ae1dc
Version
6
Effective date
2024-12-03
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:50

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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than more than 6 doses in in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Ask a doctor before use if the user has liver disease. 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. Sore throat warning: If sore throat is severe, persistent for more than 2 days, or is accompanied or followed by a fever, headache, nausea, rash, or vomiting, consult a physician promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 3 days for fever unless directed by a doctor for more that 10 days for pain unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if Stop use and ask a doctor if symptoms do not improve new symptoms occur pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If Pregnant or breast-feedinging If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. KEEP OUT OF REACH OF CHILDREN. Overdose warning: Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as 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.