FDA label 96218014-950b-f397-e053-2a95a90a190d

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
85fcde3c-c59f-4f2b-a574-ffe35a39056d
SPL ID
96218014-950b-f397-e053-2a95a90a190d
Version
3
Effective date
2019-10-30
Source export date
2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:44

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 asprin. Allergy alert-do not use if you are allergic to asprin 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 (perscription or nonperscription). Ask a doctor orpharmacist 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 drugs (NSAIDs), which may cause severe 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 NSAIDs [aspirin, ibuprofen, naproxen, or others] 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 a doctor before using if you have asthma gastric ulcers bleeding problems stomach problems (such as heartburn, upset stomach or stomach pain) 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 new symptoms occur pain or fever persists or gets worse redness or swelling is present 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(1-800-222-1222). 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.