warnings
Warnings
FDA label 57553fbf-e04c-4bb3-8a1e-3cdb7fd52f52
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
- e4b05cbc-526e-4a03-a943-631a0feb6947
- SPL ID
- 57553fbf-e04c-4bb3-8a1e-3cdb7fd52f52
- Version
- 1
- Effective date
- 2011-08-01
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:29:21
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 | 57553fbf-e04c-4bb3-8a1e-3cdb7fd52f52 | id | |
| spl set id | e4b05cbc-526e-4a03-a943-631a0feb6947 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets 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 Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use.
warnings and cautions
Warnings Do not use if allergic to iodine in the eyes For external use only Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs Avoid pooling beneath patient Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.