FDA label 16b17be2-f5bc-48bd-a5a0-91e22a6de261

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
b82af836-fd04-4cfe-9fae-84b1ee152663
SPL ID
16b17be2-f5bc-48bd-a5a0-91e22a6de261
Version
4
Effective date
2021-11-02
Source export date
2026-10-23
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-23/3250007f17a90cba640d3cc6ab3c68bf5c4eb5421ff159b460d5d7f03bc72452/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
003b0607e7bf4d3ce17ccc0942e221303b4f62b17a6a00c54547eda454293380
Import run
20261026T035824Z
Imported at
2026-10-26 04:42:31

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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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. (1800-222-1222)

Reported adverse events (FAERS/openFDA)#

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