FDA label ae685685-c04c-4eea-a445-1442014415ea

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
bade9e73-0f28-4914-ad25-fe11493d9c27
SPL ID
ae685685-c04c-4eea-a445-1442014415ea
Version
1
Effective date
2019-05-31
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 05:23:33

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 who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behaviour with nausea and vomiting occur, consult a doctor, because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Alergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away. Allergy Alert: Aspirin may cause a severe allergic reaction, which may include: • hives • facial swelling • asthma (wheezing) • shock Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Stomach Bleeding Warning: This product contains an NSAID, 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 with other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Caffeine Warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use: • with any other product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • with any other pain reliever/fever reducer • if you are allergic to aspirin • 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 Ask doctor before using if you have: • stomach problems (such as heartburn, upset stomach or stomach pain) • stomach bleeding warning applies to you • gastric ulcers • bleeding problems • you have asthma, high blood pressure, heart disease, liver disease, or kidney disease • you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for: •anticoagulation (thinning of blood) • diabetes • gout • arthritis • und a doctor's care for any serious condition • taking any other 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, have stomach pain that does not get better. These are signs of stomach bleeding. • an allergic reaction occurs. Seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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