FDA label e0df8d5a-b84f-c0c5-e053-2995a90a70ec

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
7212eddc-7483-4df5-8255-6b502db37757
SPL ID
e0df8d5a-b84f-c0c5-e053-2995a90a70ec
Version
3
Effective date
2022-06-07
Source export date
2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:49:36

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 (10.15 mL unit dose cups) Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 unit dose cups (3,250 mg) in 24 hours for adults or 5 unit dose cups (1,625 mg) in 24 hours for children, which is the maximum daily amount for this product. Severe liver damage may occur if adult takes more than 10 unit dose cups (101.50 mL) in 24 hours child takes more than 5 unit dose cups (50.75 mL) in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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.

warnings

Warnings (20.30 mL unit dose cups) Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 5 unit dose cups (3,250 mg) in 24 hours for adults, which is the maximum daily amount for this product. Severe liver damage may occur if adult takes more than 5 unit dose cups (101.50 mL) in 24 hours taken with other drugs containing acetaminophen adult has 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.

Reported adverse events (FAERS/openFDA)#

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