FDA label 8d059a3b-2fb4-4801-a50a-e0eeca2cb4fc

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
738e7767-42de-4076-acf2-9152484c2007
SPL ID
8d059a3b-2fb4-4801-a50a-e0eeca2cb4fc
Version
1
Effective date
2012-06-19
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 01:25:49

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

Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. When using this product drowsiness may occur avoid alcoholic beverages alcohol and sedatives may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Ask a doctor before use if you are taking tranquilizers or sedatives Ask a doctor before use if you have glaucoma emphysema asthma chronic pulmonary disease trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if pain persists for more than 10 days, or redness is present, or in conditions affecting children 12 years of age, consult a physician immediately if relief does not occur within 3 days, discontinue use and consult a physician

Reported adverse events (FAERS/openFDA)#

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