FDA label c62a329f-508f-78ad-e053-2a95a90a9b2a

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
9b43f780-b832-6234-e053-2a95a90aa681
SPL ID
c62a329f-508f-78ad-e053-2a95a90a9b2a
Version
2
Effective date
2021-07-02
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:09:48

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings: Reye’s syndrome: Children and teenagers should not use this medicine for chickenpox 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 a non-steroidal anti-inflammatory drug (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 ■ with large amounts of caffeinated products Ask a doctor before use if you have: ■ asthma, liver, kidney, high blood pressure or heart disease ■ stomach problems (such as heartburn, upset or painful stomach) ■ gastric ulcers ■ bleeding problems ■ taking a diuretic ■ or if the stomach bleeding warning applies to you Ask a doctor or pharmacist before use if you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis ■ with other drugs or conditions When using this product do not exceed the recommended dose. Stop use and ask a doctor if: ■ ringing in the ears or loss of hearing occurs ■ pain or fever persists or worsens ■ new symptoms occur ■ allergic reaction, redness or swelling is present If pregnant or breast-feeding a baby, 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.

warnings and cautions

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.

warnings and cautions

Stomach Bleeding Warning: This product contains a non-steroidal anti-inflammatory drug (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.

Reported adverse events (FAERS/openFDA)#

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