FDA.reportPublic FDA data

FDA label ad2108e6-1fd3-434a-bf84-ce2a3a54c5eb

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
bcf07c4c-fcca-43a0-9229-8ccd814c2832
SPL ID
ad2108e6-1fd3-434a-bf84-ce2a3a54c5eb
Version
3
Effective date
2012-11-08
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 02:49:20

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

Precautions and warnings: Reye's Syndrome: Do not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome in children under 14 years, a rare but serious illness reported to be associated with aspirin. Patients with chronic respiratory (obstructive) and allergic rhinitis could be reactivated with nonsteroidal analgesic. This product contains sodium, which could affect people with dietary restrictions of that element.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions: Occasionally nausea may occur and / or vomiting. May cause hypersensitivity reactions (Skin rashes).

Reported adverse events (FAERS/openFDA)#

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