FDA label 29bc2f0e-d303-7185-e063-6394a90ad816

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
fdfebc9f-4775-4da4-9bb0-8175e67f93c4
SPL ID
29bc2f0e-d303-7185-e063-6394a90ad816
Version
3
Effective date
2024-12-20
Source export date
2026-11-06
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:45:04

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: Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours,which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or non-prescription). 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 the product for more than 10 days for pain, unless directed by a doctor for more than 3 days for fever, unless directed by a doctor. Ask a doctor before use: if you have liver disease if you are taking the blood thinning drug warfarin. Stop using this product 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 n redness or swelling is present These could be signs of a serious condition. Warnings: May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor. Use caution when driving motor vehicle or operating machinery. Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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