FDA label f18ec92d-392b-bfa5-e053-2a95a90a4545

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
715d92bc-7df2-4f7d-bc91-305c4c4c54e4
SPL ID
f18ec92d-392b-bfa5-e053-2a95a90a4545
Version
3
Effective date
2023-01-05
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:08:28

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 u symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy Alert: Do not take this product if after taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen and aspirin or other pain relievers/fever reducers. Acetaminophen and aspirin may cause liver damage and stomach bleeding. Ask a doctor before use if you have: • the worst headache of your life • ulcers • fever and sti neck • asthma • bleeding problems • liver disease • renal disease When using this product: • limit the use of caffeine containing medications, foods, or beverages while taking this product because too much caFFeine may cause nervousness, sleeplessness, irritability and, occasionally, rapid heart beat. Stop use and ask a doctor if: • headache pain worsens or continues for more than 48 hours • new or unexpected symptoms occur • ringing in the ears or loss of hearing occur