FDA label 0b76ccb6-83c2-ee30-e063-6394a90a414b

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
f78330ba-b19e-3024-e053-6294a90a031a
SPL ID
0b76ccb6-83c2-ee30-e063-6394a90a414b
Version
9
Effective date
2023-12-01
Source export date
2026-11-06
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:27:51

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 doses 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 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 doses 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 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 Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.