warnings
Warnings
Acetaminophen
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
- Generic name
- ACETAMINOPHEN
- Manufacturer
- Granules USA, Inc
- Product type
- HUMAN OTC DRUG
- SPL set ID
- a1255f60-b9c6-9a95-e053-2995a90a9e80
- SPL ID
- 468e5f4e-8bc6-6b97-e063-6294a90a0166
- Version
- 8
- Effective date
- 2025-12-22
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:08:48
| 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 number | M013 | openfda.application_number | |
| brand name | Acetaminophen | openfda.brand_name | |
| generic name | ACETAMINOPHEN | openfda.generic_name | |
| manufacturer name | Granules USA, Inc | openfda.manufacturer_name | |
| ndc | package | 69848-003-10 | openfda.package_ndc |
| ndc | package | 69848-003-24 | openfda.package_ndc |
| ndc | package | 69848-003-17 | openfda.package_ndc |
| ndc | product | 69848-003 | openfda.product_ndc |
| ndc11 | package | 69848000317 | derived:openfda.package_ndc |
| ndc11 | package | 69848000324 | derived:openfda.package_ndc |
| ndc11 | package | 69848000310 | derived:openfda.package_ndc |
| rxcui | 198440 | openfda.rxcui | |
| spl id | 468e5f4e-8bc6-6b97-e063-6294a90a0166 | id | |
| spl set id | a1255f60-b9c6-9a95-e053-2995a90a9e80 | set_id | |
| unii | 362O9ITL9D | openfda.unii |
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 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product
warnings
Allergy alert acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.