FDA label 364bc5af-2466-42a5-825c-e0292caff85f

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
0df26073-bfe6-4884-b359-18bce19a3016
SPL ID
364bc5af-2466-42a5-825c-e0292caff85f
Version
2
Effective date
2019-08-26
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:15

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: Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product Stomach Bleeding Warning: This product contains nonsteroidal anti-inflammatory drugs (NSAIDs) which may cause stomach bleeding. The chance is higher if you: • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • you take more or for a longer time than directed Do not use: • if you are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an allergic reaction to any other pain reliever/fever reducer • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor • with any other product containing acetaminophen Ask doctor before using if you have: • asthma • stomach problems (such as heartburn, upset stomach or stomach pain) • gastric ulcers • bleeding problems Ask a doctor or pharmacist before use if you are taking a prescription drug for: •anticoagulation (thinning of blood) • diabetes • gout • arthritis When using this product do not exceed recommended dose. Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present

Reported adverse events (FAERS/openFDA)#

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