FDA label b7018369-5320-402f-9a92-bbd6fbe17954

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
47fe30db-d059-46b9-892b-7871ea161d97
SPL ID
b7018369-5320-402f-9a92-bbd6fbe17954
Version
3
Effective date
2011-01-25
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:11:53

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 DO NOT USE THIS PRODUCT TO SEDATE CHILDREN Do not use more than the recommended dosage. If drowsy, do not drive or operate machinery. this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease or difficulty breathing. When using this product Do not drink alcohol when taking this product. May increase activity level especially in children. *See Directions Ask a doctor before use is you have Difficulty in urination due to enlargement of the prostate gland. High blood pressure, heart disease, diabetes or thyroid disease. Stop use a nd ask a doctor if Symptoms last more than seven days, returns or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. Chicken Pox or flu symptoms are present, especially in teenagers or children.* See Directions If pregnant or breast-feeding , Do Not 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.