FDA label 1a930ddb-c405-471f-8c1b-c836e7a3d2f3

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
d49b5b7f-59af-40c5-a0ec-79f5bf8aa56c
SPL ID
1a930ddb-c405-471f-8c1b-c836e7a3d2f3
Version
1
Effective date
2015-04-05
Source export date
2026-11-06
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:58:36

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

Reported adverse events (FAERS/openFDA)#

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