Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6484c373-697f-4a81-a375-8cb97223a42c
Route
ORAL
Published
Effective Date 2024-03-20
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 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: P51 Shape: oval Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-01

Description

Docusate sodium 100 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Uses
  • for relief of 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 Labeling
EQUATE 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 1-888-287-1915

Principal Display Panel

†Compare to the active ingredient in Dulcolax® Stool Softener

Stool Softener

Docusate Sodium 100 mg

Stool Softener Laxative

  • Comfortable relief of painful, hard, dry stools
  • 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.

DISTRIBUTED BY: Wal-Mart Inc.,

Bentonville,AR 72716

Stop Use and Ask A Doctor If
  • you have rectal bleeding or no bowel movement after using 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 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Structured Label Content

Uses
  • for relief of 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 Labeling
EQUATE 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 1-888-287-1915

Principal Display Panel

†Compare to the active ingredient in Dulcolax® Stool Softener

Stool Softener

Docusate Sodium 100 mg

Stool Softener Laxative

  • Comfortable relief of painful, hard, dry stools
  • 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.

DISTRIBUTED BY: Wal-Mart Inc.,

Bentonville,AR 72716

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or no bowel movement after using 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 100 mg

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)