FDA label 8ddcf2ef-2951-4122-91fe-3e1bd25f3def

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
27898e8b-8e5b-4c17-b405-2012adb431b0
SPL ID
8ddcf2ef-2951-4122-91fe-3e1bd25f3def
Version
1
Effective date
2011-01-20
Source export date
2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:52

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. If pain or fever persist, if new symptoms occur, or if redness or swelling is present, consult your physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age. Caution should be exercised when used in patients with prostatic hypertrophy, urinary retention, bladder neck obstruction, increased ocular pressure and asthma. Alcohol Warning If you consume 3 or more alcoholic drinks every day, ask you doctor whether you should take acetaminophen or other pain relievers/ fever reducers. Acetaminophen may cause liver damage.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following adverse effects have been selected on the basis of their potential clinical significance (not necessarily inclusive): allergic reactions, anemia, blood dyscrasias (sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness), psychotic episodes (mood or mental changes) - usually associated in previous history of psychiatric illness, tightness in chest.

Reported adverse events (FAERS/openFDA)#

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