FDA label 49b3a26c-8ec8-44da-a9a9-aacaae8278da

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
c538ae72-30b6-45e7-846a-dec58e49a02c
SPL ID
49b3a26c-8ec8-44da-a9a9-aacaae8278da
Version
7
Effective date
2022-12-05
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:51:26

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 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 behavior 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. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives, facial swelling, shock, asthma (wheezing) 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 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. WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. 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 definitely 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. – you may report any side effect to FDA at 1-800-FDA-1088 SKY Mfd. By: Time-Cap Labs, 7 Michael Ave., Farmingdale, NY 11735 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Road Concord, NC 28027 Distributed By: Cardinal Health Dublin, OH 43017 L4917308-10718 L4917308-20718

Reported adverse events (FAERS/openFDA)#

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