APAP

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)

Brand name
APAP
Generic name
ACETAMINOPHEN
Manufacturer
Advance Pharmaceutical Inc.
Product type
HUMAN OTC DRUG
SPL set ID
5c75dc7f-06ae-440e-90ed-d7753eaa786e
SPL ID
60f41580-e0a5-faad-e053-2a91aa0a9076
Version
2
Effective date
2017-12-22
Source export date
2026-10-27
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/a758d73d4d838a965005e6adf01b928e2da86f99be0f8bbaeeb95f3b7acbe418/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 19:56:37
Harmonized routes table
Harmonized routes
ORAL

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. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 non prescription). 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 the 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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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