FDA label d22ed91d-fd4a-6f8a-e053-2995a90aae00

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
6157820d-463a-ea51-e053-2991aa0a847b
SPL ID
d22ed91d-fd4a-6f8a-e053-2995a90aae00
Version
2
Effective date
2021-12-02
Source export date
2026-08-01
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/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:26

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 teenages who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an eary sign of Reye's syndrome, a rare but serious illnes. ALLERY ALERT Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (sheezing) 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 usng 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 (anticogulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others) 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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.