FDA label 29f1eb29-5639-331c-e063-6394a90a1b13

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
42ca9bed-16f0-4f1b-abda-4a7bd0cbb227
SPL ID
29f1eb29-5639-331c-e063-6394a90a1b13
Version
5
Effective date
2024-12-23
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:46:43

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 Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes trouble urinating due to the enlargement of the prostate gland a cough that occurs with too much phlegm (mucus) cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema When using this product, do not exceed recommended dosage Stop use and ask doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition

Reported adverse events (FAERS/openFDA)#

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