boxed warning
TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
FDA label 3b4f6475-71e3-4ef6-8931-584d1bf7f3d5
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
- 375ba5bf-16c1-4912-9aa1-a8e7196aed31
- SPL ID
- 3b4f6475-71e3-4ef6-8931-584d1bf7f3d5
- Version
- 2
- Effective date
- 2017-03-28
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:48:10
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 | 3b4f6475-71e3-4ef6-8931-584d1bf7f3d5 | id | |
| spl set id | 375ba5bf-16c1-4912-9aa1-a8e7196aed31 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
boxed warning
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
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 2 tables 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.