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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 8ddcf2ef-2951-4122-91fe-3e1bd25f3def | id | |
| spl set id | 27898e8b-8e5b-4c17-b405-2012adb431b0 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.