warnings
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
FDA label 46237e8d-f0c8-406d-8de8-234693b2a98e
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
- dcb85ae7-2812-4a71-84e6-92b007e9c480
- SPL ID
- 46237e8d-f0c8-406d-8de8-234693b2a98e
- Version
- 2
- Effective date
- 2017-12-05
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:42:17
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 | 46237e8d-f0c8-406d-8de8-234693b2a98e | id | |
| spl set id | dcb85ae7-2812-4a71-84e6-92b007e9c480 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings: Reye's syndrome: Children and teenagers should not use this drug for chicken pox or flu symptoms before a doctor is asked about Reye's Syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives, facial swelling, shock, asthma (wheezing) Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. SKY Mfd. By: Time-Cap Labs, 7 Michael Avenue Farmingdale, NY 11735 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Road Concord, NC 28027 Repackaged by: Cardinal Health Zanesville, OH 43701 L3568193-10413A L3568193-20413A
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.