Prolaxa

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: Prolaxa
Generic name: DOCUSATE SODIUM 250MG
Manufacturer: Advanced Rx of Tennessee, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d
SPL ID: 3ba0c7e2-c13b-a7d7-e063-6394a90abf07
Version: 1
Effective date: 2025-08-05
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:33

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		Prolaxa	openfda.brand_name
generic name		DOCUSATE SODIUM 250MG	openfda.generic_name
manufacturer name		Advanced Rx of Tennessee, LLC	openfda.manufacturer_name
ndc	package	80425-0540-1	openfda.package_ndc
ndc	product	80425-0540	openfda.product_ndc
ndc11	package	80425054001	derived:openfda.package_ndc
rxcui		2711894	openfda.rxcui
rxcui		1245468	openfda.rxcui
spl id		3ba0c7e2-c13b-a7d7-e063-6394a90abf07	id
spl set id		3ba0c0d9-9e6f-a2e6-e063-6394a90a202d	set_id
unii		F05Q2T2JA0	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 Do not use if you are presently taking mineral oil, unless directed by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that last over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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