FDA label f94acedd-48ee-4dbd-9243-a45599fe53d4

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
5033f9f6-9b77-4871-ab29-b10174ba8667
SPL ID
f94acedd-48ee-4dbd-9243-a45599fe53d4
Version
11
Effective date
2010-12-18
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:28

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

WARNINGS AND PRECAUTIONS Do not exceed recommended dosage. This drug may make you dizzy or drowsy or cause blurred vision; use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. Limit alcohol consumption. Cross sensitivity and/or related problems – patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers. There have been no studies to establish the safety of prolonged use of this product in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficulty micturition, acute urinary retention Gastrointestinal: dry mouth, nausea and vomiting Respiratory: shortness of breath or trouble breathing Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue-green. This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. The following number does not provide medical advice, but in the U.S. you may report suspected side effects to the FDA at 1-800-FDA-1088.

Reported adverse events (FAERS/openFDA)#

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