Prolaxa

Prolaxa
SPL v1
SPL
SPL Set ID 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d
Route
ORAL
Published
Effective Date 2025-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (250 mg)
Inactive Ingredients
Gelatin Sorbitan Propylene Glycol Glycerin Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: C76 Shape: capsule Color: yellow Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-05

Description

Docusate sodium 250 mg - Extra Strength

Purpose

 Stool softener laxative


Medication Information

Purpose

 Stool softener laxative

Description

Docusate sodium 250 mg - Extra Strength

Uses
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours
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
Do Not Use

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

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.

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 [email protected]

Package Label; Display Panel

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.

Active Ingredient (in Each Softgel)

Docusate sodium 250 mg - Extra Strength

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Structured Label Content

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

 Stool softener laxative

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
Do Not Use (Do not use)

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

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.

Other Information (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? (Questions or comments?)

Call toll free (877) 985-8377 or [email protected]

Package Label; Display Panel

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 250 mg - Extra Strength

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)