drug facts

drug facts
SPL v4
SPL
SPL Set ID 4e97dd60-96e3-4b51-b614-c62480af1919
Route
oral
Published
Effective Date 2025-08-19
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 completed Since 2021-06-25 Until 2026-12-31

Purpose

 Stool softener laxative

Description

 Docusate sodium 250 mg


Medication Information

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
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 

Description

 Docusate sodium 250 mg

Principal Display Panel

extra strength

stool softener

docusate sodium 250 mg

stool softener laxative

  • Stimulant-free
  • relief of constipation

softgels

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

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Do Not Use

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

Product Label
WELLNESS BASICS Extra Strength Stool Softener
Questions Or Comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

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
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 

Principal Display Panel

extra strength

stool softener

docusate sodium 250 mg

stool softener laxative

  • Stimulant-free
  • relief of constipation

softgels

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

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Do Not Use (Do not use)

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

Product Label
WELLNESS BASICS Extra Strength Stool Softener
Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

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)