warnings
Warnings
FDA label 54ae55e0-1f4a-072e-e054-00144ff88e88
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
- 4ecda7b5-f03d-5108-e054-00144ff88e88
- SPL ID
- 54ae55e0-1f4a-072e-e054-00144ff88e88
- Version
- 3
- Effective date
- 2017-07-19
- Source export date
- 2026-09-28
- 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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:13:38
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 | 54ae55e0-1f4a-072e-e054-00144ff88e88 | id | |
| spl set id | 4ecda7b5-f03d-5108-e054-00144ff88e88 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 10 softgels in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product
warnings
Allergy alert acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • skin reddening • blisters • rash • hives • facial swelling • asthma (wheezing) • shock If a skin or allergic reaction occurs, stop use and seek medical help right away.
warnings
Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.