Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b1d903a5-1d5f-44d4-9939-a4b86e5a620d
Route
ORAL
Published
Effective Date 2024-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Sorbitan Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: P51 Shape: oval Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-31

Description

Docusate Sodium 100 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses
  • for temporary relief occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Directions
  • take with a glass of water
adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor
Do Not Use

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

Product Label
EQUALINE Stool Softener Laxative
Other Information
  • each softgel contains: sodium 5 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol,  purified water sorbitan, sorbitol

Questions Or Comments?

 Call toll free 1-855-423-2630

Principal Display Panel

compare to Dulcolax® Stool Softener active ingredient†

stool softener

docusate sodium 100 mg

stool softener laxative

  • comfortable relief of painful, hard, dry stool
  • stimulant-free
  • constipation relief

Softgels

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

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 a 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 100 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 temporary relief occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • take with a glass of water
adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor
Do Not Use (Do not use)

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

Product Label
EQUALINE Stool Softener Laxative
Other Information (Other information)
  • each softgel contains: sodium 5 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol,  purified water sorbitan, sorbitol

Questions Or Comments? (Questions or comments?)

 Call toll free 1-855-423-2630

Principal Display Panel

compare to Dulcolax® Stool Softener active ingredient†

stool softener

docusate sodium 100 mg

stool softener laxative

  • comfortable relief of painful, hard, dry stool
  • stimulant-free
  • constipation relief

Softgels

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

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 a 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 100 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)