FDA label 00a8f2c9-f087-456e-b9e6-c07eb71b8f86

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
12f92dd0-5c7c-46f1-a44a-64af0f26686d
SPL ID
00a8f2c9-f087-456e-b9e6-c07eb71b8f86
Version
14
Effective date
2014-06-27
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:51:43

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 5 doses 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 Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Alcohol warning: If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Do not use with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if the user is allergic to acetaminophen or any of the inactive ingredients in this product When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose Warning : In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms.

Reported adverse events (FAERS/openFDA)#

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