FDA label 58d054da-c20f-4c4a-bea0-56cef5c5c95b

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
bc609bde-4afb-41ec-b222-bcc3f683dfc7
SPL ID
58d054da-c20f-4c4a-bea0-56cef5c5c95b
Version
3
Effective date
2020-06-24
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:42:28

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

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: Magnesium Salicylate 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 • 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 Ask a doctor before use if : Stomach bleeding warnings apply to you, you have a history of stomach problems such as heartburn, you have asthma, high blood pressure, heart disease, liver disease or kidney disease Do not use: • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • When using this product do not exceed recommended dose. Do not use: • if you are allergic to aspirin or salicylates • 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 Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present Ask a doctor or pharmacist before use if you are taking a prescription drug for: • anticoagulation (thinning of blood) • diabetes • gout • arthritis Stop use and ask a doctor if: An allergic reaction occurs. Seek medical help right away. You experience any of the following signs of stomach bleeding: feel faint, vomit blood, have black or bloody stools, have stomach pain that does not get better • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present

Reported adverse events (FAERS/openFDA)#

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