FDA.reportPublic FDA data

FDA label c5dd69d7-09b1-e160-e053-2995a90a4db2

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID
89bbf6d9-591e-f7ab-e053-2995a90a42e1
SPL ID
c5dd69d7-09b1-e160-e053-2995a90a4db2
Version
6
Effective date
2021-06-28
Source export date
2026-08-01
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:05:37

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 4 doses (8 capsules) in 24 hours, which is the maximum daily amount for this product ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.