FDA label 3081f1d4-8db1-4cc5-9c24-90b15025377f

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
cb4d8746-7974-47e9-9089-6bfac61380c1
SPL ID
3081f1d4-8db1-4cc5-9c24-90b15025377f
Version
3
Effective date
2017-03-17
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:32:49

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 Warnings: 1. The following patients should not take this drug (1) Hemorrhage or ulcer patients (2) Patients who show allergic reactions to salicylic acid or patients who are taking other drugs containing salicylic acid. (3) Children under the age of 7 (4) This drug contains lactose therefore patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or other genetic problems should not take this drug. 2. Patients with the following symptoms must consult with doctor, dentist or pharmacist before administering. (1) Diarrhea patients with fever. Senior citizens. Patients with bloody excrement or mucous stool. (2) Pregnant woman or one who maybe pregnant (4) Children (5) Patients taking other medication 3. Patients with the following symptoms must dentist or pharmacist before administering. Take the attachment when consulting. (1) Tinnitus (ringing in the ears), damage in hearing, continuous diarrhea may occur from taking this drug. (2) Leigh syndrome may occur from taking this drug. (3) If symptoms do not improve after taking this drug several times. 4. Additional notes (1) Follow guided dosage and administering method (2) Adult supervision is needed when administering to children. (3) If this drug is taken to stop severe acute diarrhea or diarrhea accompanied by vomiting, stomachache, abdominal distension and etc., symptoms may worsen. Under these situations, consult with a pharmacist or doctor about administering the drug. (4) Do not drink alcohol when taking the tablets. (5) Do not take tablets for more than 3 days.

Reported adverse events (FAERS/openFDA)#

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