Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5b8bcc6c-de03-4d73-a76f-6f4c371cf250
Route
ORAL
Published
Effective Date 2024-04-09
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 2021-04-30

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 Label
H-E-B 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: 1-877-753-3935, Monday-Friday, 9AM-5PM EST

Principal Display Panel

Compare to Dulcolax® Stool Softener active ingredient**

Stool Softener

Laxative

Docusate Sodium 100 mg

Stool Softener Laxative

Fast, Dependable Relief of Occasional Constipation

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.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

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 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 Label
H-E-B 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: 1-877-753-3935, Monday-Friday, 9AM-5PM EST

Principal Display Panel

Compare to Dulcolax® Stool Softener active ingredient**

Stool Softener

Laxative

Docusate Sodium 100 mg

Stool Softener Laxative

Fast, Dependable Relief of Occasional Constipation

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.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

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)