FDA label 60419041-dce0-a5e9-e053-2991aa0a68b3

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
41da51a4-7715-41ac-86e0-ecc3a6490a1b
SPL ID
60419041-dce0-a5e9-e053-2991aa0a68b3
Version
3
Effective date
2017-12-13
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:53

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. Allergy Alert -Do not use: • if you are allergic to aspirin or any other salicylate • if you have ever had an allergic reaction to any other pain reliever/fever reducer Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours • with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • 3 or more alcoholic drinks every day while using this product Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others. • Take more or for a longer time than directed Do not use: • with 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: • upset stomach or stomach pain • ulcers • bleeding problems • high blood pressure • heart or kidney disease • taken a diuretic • reached age 60 or older Ask a doctor or pharmacist b efore use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug 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 • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding If pregnant or breast-feeding , ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a 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. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a 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.