FDA label 1f5a9653-ad96-4723-8ec2-4e0815495c66

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
cfc785c6-870f-45a7-86a5-d9b9de06dd8c
SPL ID
1f5a9653-ad96-4723-8ec2-4e0815495c66
Version
1
Effective date
2013-10-23
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:41:08

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 BOTTLE FOR ADDITIONAL WARNINGS AND PRODUCT INFORMATION. Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 6 caplets in 24 hours, which is the maximum daily amount for this product With other drug containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have: Liver disease Glaucoma Difficulty in urination due to enlargement of the prostate gland A breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin Taking sedatives or tranquilizers When using this product: You may get drowsy Avoid alcoholic drinks Excitability may occur, especially in children Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains as a cup of coffee. Stop use and ask a doctor if: new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days If pregnant or breast feeding ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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