FDA label 896e0b77-09de-4832-9c3d-d273005e5b43

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
c3b408ff-f47b-4fee-ade5-5db6e25f4ee0
SPL ID
896e0b77-09de-4832-9c3d-d273005e5b43
Version
1
Effective date
2010-06-30
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:30

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Liver Warning: this product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maxium daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days These could be sign of a serious condition If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. Enter section text here 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

warnings

Liver Warning: this product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maxium daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Reported adverse events (FAERS/openFDA)#

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