PROLAXA- docusate sodium 250mg capsule, liquid filled

Prolaxa by

Drug Labeling and Warnings

Prolaxa by is a Otc medication manufactured, distributed, or labeled by Terrain Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 250 mg - Extra Strength

Purpose

 Stool softener laxative

Uses

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

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.

Directions

• 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

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

Inactive Ingredients

GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, SORBITAN

Questions or comments?

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

Prolaxa™

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

Prolaxa™ Drug Facts

INGREDIENTS AND APPEARANCE

PROLAXA 
docusate sodium 250mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53225-2001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
SORBITAN (UNII: 6O92ICV9RU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	yellow (NAT-00 - Clear/Yellow)	Score	no score
Shape	CAPSULE (Oblong)	Size	9mm
Flavor		Imprint Code	C76
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53225-2001-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/15/2025

Labeler - Terrain Pharmaceuticals (078358750)