FDA label 6025ae3b-4a18-e618-e053-2a91aa0a57ca

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
cd1675ec-b989-4e7c-90aa-2751c2326282
SPL ID
6025ae3b-4a18-e618-e053-2a91aa0a57ca
Version
2
Effective date
2017-12-12
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:31:23

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: ALCOHOL WARNING: Do not use alcoholic beverages while taking this product. May cause marked drowsiness: alcohol, sedatives and tranquilizers may increase the dowsiness effect DO NOT USE UNLESS DIRECTED BY YOUR PHYSICIAN IF You are using prescription drugs You are using sedatives or tranquilizers You are currently under a doctor's care You have glaucoma You have emphysema You have chronic pulmonary disease You have shortness of breath or difficulty in breathing You have difficulty in urination due to enlargement of the prostate gland When using this product Use the smallest effective dose Do not use more than directed. This product is not for frequent or prolonged use unless on the advice of a doctor Use caution when driving a motor vehicle or operating machinery STOP USING AND ASK A DOCTOR IF Nervousness, dizziness or sleeplessness occur Conditions worsen or new symptoms occur Keep this and all medicines out of the reach of children. Do not exceed recommended dose. In case of accidental overdose, contact a physician or poison control center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If you are pregnant or nursing a baby, as with any drug, seek the advice of a health professsional before using this product.