FDA label c1e88403-d3c5-459c-948c-6bea82b76e0e

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
4cfdbdbe-1126-4566-6aba-4813c074d2f5
SPL ID
c1e88403-d3c5-459c-948c-6bea82b76e0e
Version
3
Effective date
2011-08-29
Source export date
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:09

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 Use in Children: Safety and efficacy have not been established in the pediatric age group; therefore, the use of procyclidine hydrochloride in this age group requires that the potential benefits be weighed against the possible hazards to the child. Pregnancy Warning: The safe use of this drug in pregnancy has not been established; therefore, the use of procyclidine hydrochloride in pregnancy, lactation, or in women of childbearing age requires that the potential benefits be weighed against the possible hazards to the mother and child.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Anticholinergic effects can be produced by therapeutic doses although these can frequently be minimized or eliminated by careful dosage. They include: dryness of the mouth, mydriasis, blurring of vision, giddiness, lightheadedness, and gastrointestinal disturbances such as nausea, vomiting, epigastric distress, and constipation. Occasionally an allergic reaction such as a skin rash may be encountered. Feelings of muscular weakness may occur. Acute suppurative parotitis as a complication of dry mouth has been reported.

Reported adverse events (FAERS/openFDA)#

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