FDA label ad69294e-7f51-4db0-e053-2a95a90a39cf

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
867953d6-8746-45be-b656-336daaa1d968
SPL ID
ad69294e-7f51-4db0-e053-2a95a90a39cf
Version
3
Effective date
2020-08-21
Source export date
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:41

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 May cause excitability, especially in children Ask a doctor before use if your child has glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if the child is taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if: new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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