Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID dcd27653-4c81-4630-a8b7-5fb5dc3e976a
Route
ORAL
Published
Effective Date 2024-03-13
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 Mannitol Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: P20 Shape: capsule Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-30

Description

Docusate sodium 250 mg

Purpose

 Stool softener laxative


Medication Information

Purpose

 Stool softener laxative

Description

Docusate sodium 250 mg

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.

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

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol



Questions Or Comments?

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

Principal Display Panel

EXTRA STRENGTH

Stool Softener

DOCUSATE SODIUM, 250 mg

Stool Softener Laxative

Relieves occasional constipation

  • Gentle stool softener
  • reliable relief
  • stimulant free

SOFTGELS

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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
  • 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.

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

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol



Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

EXTRA STRENGTH

Stool Softener

DOCUSATE SODIUM, 250 mg

Stool Softener Laxative

Relieves occasional constipation

  • Gentle stool softener
  • reliable relief
  • stimulant free

SOFTGELS

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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)