FDA label fb1b88cc-c8d9-4efd-a137-d1b04440fbc0

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
1d3f2e2b-2600-4bdc-8653-59f3909f1031
SPL ID
fb1b88cc-c8d9-4efd-a137-d1b04440fbc0
Version
17
Effective date
2020-05-19
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:34

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 See New Warnings Information and Directions This unit dose package is not child resistant and is intended for institutional use only. Keep out of reach of children. Tamper Evident: Do not use if sealed blister units are broken or damaged. Liver Warning This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours- with other drugs containing acetaminophen, - 3 or more alcoholic drinks every day while using this product. Symptoms may include: - skin reddening – blisters – rash If skin reactions 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 inactive 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 lasts more than 10 days. fever gets worse or lasts more than 3 days. new symptoms occur. redness or swelling is present. These could be signs of a serious condition. Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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