warnings
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Acetaminophen and Ibuprofen (NSAID)
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
- Brand name
- Acetaminophen and Ibuprofen (NSAID)
- Generic name
- ACETAMINOPHEN AND IBUPROFEN (NSAID)
- Manufacturer
- RETAIL BUSINESS SERVICES,LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e7b7009a-89a4-720d-e053-2a95a90abff7
- SPL ID
- 4652acf2-7ec6-eff9-e063-6294a90ac499
- Version
- 6
- Effective date
- 2025-12-19
- Source export date
- 2026-10-22
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-22/0bafccaf0213baa649cda9c1c2365d28432e10cf46f4167b2ea41290b5cac2b8/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
- Import run
- 20261023T001338Z
- Imported at
- 2026-10-23 01:04:02
| Harmonized routes |
|---|
| ORAL |
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 |
|---|---|---|---|
| application applno | ANDA | 216592 | derived:openfda.application_number |
| application number | ANDA216592 | openfda.application_number | |
| brand name | Acetaminophen and Ibuprofen (NSAID) | openfda.brand_name | |
| generic name | ACETAMINOPHEN AND IBUPROFEN (NSAID) | openfda.generic_name | |
| manufacturer name | RETAIL BUSINESS SERVICES,LLC | openfda.manufacturer_name | |
| ndc | package | 72476-131-81 | openfda.package_ndc |
| ndc | package | 72476-131-72 | openfda.package_ndc |
| ndc | product | 72476-131 | openfda.product_ndc |
| ndc11 | package | 72476013181 | derived:openfda.package_ndc |
| ndc11 | package | 72476013172 | derived:openfda.package_ndc |
| rxcui | 2387532 | openfda.rxcui | |
| spl id | 4652acf2-7ec6-eff9-e063-6294a90ac499 | id | |
| spl set id | e7b7009a-89a4-720d-e053-2a95a90abff7 | set_id | |
| unii | WK2XYI10QM | openfda.unii | |
| unii | 362O9ITL9D | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.