DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

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)

Brand name
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Generic name
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Manufacturer
Direct Rx
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
d9a36478-4788-4107-e053-2a95a90ad6da
SPL ID
2c3d9a97-2f79-1c66-e063-6294a90ab5c4
Version
5
Effective date
2025-01-21
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 05:26:33
Harmonized routes table
Harmonized routes
ORAL

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

The following serious adverse reactions are described elsewhere in labeling: Respiratory and/or CNS depression (see WARNINGS) Anticholinergic and opioid-toxicities, including atroponism (see WARNINGS and PRECAUTIONS) Dehydration and electrolyte imbalance (see WARNINGS) GI Complications in patients with infectious diarrhea (see WARNINGS) Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS) At therapeutic doses of diphenoxylate hydrochloride and atropine sulfate tablets, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

Reported adverse events (FAERS/openFDA)#

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