FDA label db51e3a4-248b-4c92-a046-516e95e85a8f

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
a7424b9f-f2c0-4289-962d-99c2354c5a60
SPL ID
db51e3a4-248b-4c92-a046-516e95e85a8f
Version
2
Effective date
2016-10-25
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:41:39

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 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Do not exceed recommended dose. Do not use with other products 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 you have liver disease glaucoma difficulty in urination due to an enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product you may get drowsy excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if new symptoms occur redness or swelling is present pain persists for more than 10 days. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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