Prolaxa

Manufacturer: Advanced Rx of Tennessee, LLC
Effective date: 2025-08-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:09:21

Label at a glance#

ProductProlaxa

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Indications and uses

for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Contacts and useful links#

PhoneLabel contact(877) 985-8377

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 250 mg - Extra Strength

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, SORBITAN

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free (877) 985-8377 or info@terrainrx.com

Prolaxa™

DESCRIPTION SECTION

PROLAXA™

Stool Softener

DOCUSATE SODIUM, 250 mg

STOOL SOFTENER LAXATIVE - SOFTGELS

MAXIMUM STRENGTH
Easy to swallow
Relieves constipation
Gentle Relieve
Dependable
Stimulant Free

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label; Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prolaxa 250mg #100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1245468	docusate sodium 250 MG Oral Capsule	PSN	1
2711894	Prolaxa 250 MG Oral Capsule	PSN	1
2711894	docusate sodium 250 MG Oral Capsule [Prolaxa]	SBD	1
1245468	docusate sodium 250 MG Oral Capsule	SCD	1
1245468	DOSS Sodium 250 MG Oral Capsule	SY	1
2711894	DOSS sodium 250 MG Oral Capsule [Prolaxa]	SY	1
2711894	Prolaxa 250 MG Oral Capsule	SY	1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0540-1	Prolaxa	100 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0540-1	EA - Each	80425-0540	19973467-6708-4b6b-83a2-3a5b20f2a0fb	1	2025-09-12
53225-2001-1	EA - Each	53225-2001	aa1310eb-6faa-4bfc-a75f-85befacab3b4	1	2025-06-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Prolaxa
Docusate Sodium 250mg
GELATIN
SORBITAN
PROPYLENE GLYCOL
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
DOCUSATE SODIUM
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80425-0540	80425-0540-1
53225-2001

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GELATIN	2G86QN327L	IACT
SORBITAN	6O92ICV9RU	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prolaxa	DOCUSATE SODIUM 250MG	Advanced Rx of Tennessee, LLC	3ba0c0d9-9e6f-a2e6-e063-6394a90a202d	2025-08-05	Warnings	Exact identifier ndc (package): 80425-0540-1 ndc (product): 80425-0540 ndc11 (package): 80425054001 spl id: 3ba0c7e2-c13b-a7d7-e063-6394a90abf07 spl set id: 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d
Prolaxa	DOCUSATE SODIUM 250MG	Terrain Pharmaceuticals	32610e42-f352-09fd-e063-6394a90abff6	2025-06-12	Warnings	Exact identifier ndc (product): 53225-2001

Reported adverse events (FAERS/openFDA)#

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