FDA label ec4ac548-79ed-45d3-b97a-96e8678e9b67

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
1fce1cb3-2086-4cfc-90e5-f718b6bf2eaa
SPL ID
ec4ac548-79ed-45d3-b97a-96e8678e9b67
Version
3
Effective date
2019-09-13
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:58

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 with this product if you take: more than 2 geltabs 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 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Do not use with other product containing acetaminophen (prescription or non prescription) if you are not sure whether a drug contain acetaminophen ask a doctor or pharmacist Ask a doctor before use if you have liver disease asthma glaucaoma Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks Stop use and ask a doctor new symptoms occur pain gets worse or last more than 10 days fever gets worse or last more than 3 days If pregnant or breast-feeding ask a health care or professional before use Keep out of reach of children keep out of reach of children

Reported adverse events (FAERS/openFDA)#

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