FDA label b0c52edf-9185-4913-a052-a5f6ae916b0f

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
17174e2e-1130-496a-bbdd-c800b5bdf6a9
SPL ID
b0c52edf-9185-4913-a052-a5f6ae916b0f
Version
2
Effective date
2015-05-04
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:34:49

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 you take ■ more than 8 tablets in 24 hours, which is the maximum 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 Ask a Doctor before use if user has liver disease Ask a Doctor/Pharmacist before use if you are taking the blood thinning drug warfarin Stop Use and ask a doctor if ■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050 If pregnant or breast-feeding, ask a health professional before use Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage. Directions Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours; Children under 12 years of age: do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems. Other information ■ store at room temperature 59º-86º F (15º-30º C) ■ do not use if imprinted safety seal under cap is broken or missing Inactive ingredients corn starch, pregelatinized starch, stearic acid. May contain povidone and sodium starch glycolate.

Reported adverse events (FAERS/openFDA)#

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