FDA label 9824bef7-3a64-4c6b-9882-c7daf698d4a8

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
d98ffe86-9451-4473-88c7-c9fcaf9d2e62
SPL ID
9824bef7-3a64-4c6b-9882-c7daf698d4a8
Version
3
Effective date
2017-03-17
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:03:52

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. Take careful 1) Family history to urticaria, contact dermatitis, bronchial asthma, allergic rhinitis, migrane, food allergy 2) Allergy experience to this drug (fever, rash, arthritis, asthma, pruritis) 3) Disease of Liver, kidney and thyroid disease, Diabetes, hypertension, weakling, high-fever 4) Heart failure, hypertension, elderly 5) Pregnant or breast-feeding 6) Glaucoma, dysuria 7) Patients taking other drugs 8) This medicine contains yellow 4 (tartrazine) thus sensitive or allergic to these ingredients, the careful administration 2. Adverse events 1) While taking a rash, redness, nausea, vomiting, constipation, anorexia, dysuria, dizziness and other symptoms when you stop asking your doctor or pharmacist 2) If you get drowsy, Be careful when driving a motor vehicle or operating machinery 3. General caution 1) Keep direction 2) Please don’t take drug and ask doctor or pharmacist if you can not feel better by several dose. 4. Interaction Not taken with anti-tussive, expectorant, antihistamine, sedative, alcohol 5. Use for children In children under the age of 15 do not take 6. Caution of storage 1) Keep out of reach of children 2) Avoid sunlight and keep in cool and low humid place 3) Don’t abuse and replace with other container

Reported adverse events (FAERS/openFDA)#

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