Cystex PM

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: Cystex PM
Generic name: ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer: Clarion Brands, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 9668a2ca-729e-4172-80b5-33e6c5175ba4
SPL ID: 46f3c199-aa9e-b9c9-e063-6394a90a9f7e
Version: 5
Effective date: 2025-12-27
Source export date: 2026-10-30
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/2026-10-30/9dea423b9e87a781c152bc6e136923fb91acb0732a7a0ec0d2a51142148f160c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:43:00

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Cystex PM	openfda.brand_name
generic name		ACETAMINOPHEN, DIPHENHYDRAMINE HCL	openfda.generic_name
manufacturer name		Clarion Brands, LLC	openfda.manufacturer_name
ndc	package	69693-417-10	openfda.package_ndc
ndc	package	69693-417-20	openfda.package_ndc
ndc	product	69693-417	openfda.product_ndc
ndc11	package	69693041720	derived:openfda.package_ndc
ndc11	package	69693041710	derived:openfda.package_ndc
rxcui		1092189	openfda.rxcui
spl id		46f3c199-aa9e-b9c9-e063-6394a90a9f7e	id
spl set id		9668a2ca-729e-4172-80b5-33e6c5175ba4	set_id
unii		TC2D6JAD40	openfda.unii
unii		362O9ITL9D	openfda.unii

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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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