Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 2cf6c9bf-c318-445d-9306-5675b1d424b0
Route
ORAL
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (250 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Anhydrous Citric Acid Isopropyl Alcohol Lecithin, Soybean Mannitol Mineral Oil Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: P4 Shape: capsule Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-25

Description

 Docusate sodium 250 mg

Purpose

 Stool softener laxative


Medication Information

Purpose

 Stool softener laxative

Description

 Docusate sodium 250 mg

Uses
  • relieves 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.

Product Label
EQUATE Extra Strength Stool Softener
Other Information
  • each softgel contains: sodium 13 mg
  • store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink 

Questions Or Comments?

Call 1-888-287-1915

Principal Display Panel

EXTRA STRENGTH

Stool Softener

Docusate sodium 250 mg

Stool Softener Laxative

  • Stimulant-free
  • Relief of occasional constipation

SOFTGELS

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

Distributed BY: Walmart Inc.,

Bentonville, AR 72716

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

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
  • relieves 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.

Product Label
EQUATE Extra Strength Stool Softener
Other Information (Other information)
  • each softgel contains: sodium 13 mg
  • store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink 

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

Principal Display Panel

EXTRA STRENGTH

Stool Softener

Docusate sodium 250 mg

Stool Softener Laxative

  • Stimulant-free
  • Relief of occasional constipation

SOFTGELS

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

Distributed BY: Walmart Inc.,

Bentonville, AR 72716

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

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)