FDA label d441623e-643d-dd1f-e053-2a95a90aa515

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
a4738c36-c7cf-2f6f-e053-2995a90afcd0
SPL ID
d441623e-643d-dd1f-e053-2a95a90aa515
Version
6
Effective date
2021-12-28
Source export date
2026-08-08
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/08ac2ecb70ff33d04555f409cd5f90c8dfd623a13d56debe804299dfaddb62fe/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 18:01:24

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 Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 (120mL) single-use vials (4,000mg) in 24 hours. ■ with other drugs containing acetamintophen. ■ 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. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the active ingredients in this product. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if ■ pain gets worse or last more than 10 days ■ fever gets worse or last more than 3 days ■ new symptoms occur ■ redness or swelling is present. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.