Docusate Sodium 100 Mg Softgels

Docusate Sodium 100 Mg Softgels
SPL v3
SPL
SPL Set ID 025e03e0-e273-47ed-87f7-98e388abe047
Route
ORAL
Published
Effective Date 2024-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SCU2 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-01
Description

Docusate Sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate Sodium 100 mg

Uses
  • relieves occasional constipation (irregularity) 
  • generally produces bowel movement in 12 to 72 hours
Section 51945-4

PHARBEST

NDC 16103-0399-11

*Compare to the active ingredient of Colace ®

Docusate

Sodium

Stool Softener

1000 SOFTGELS

100 mg each

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

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

Warnings

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Directions
  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over                  take 1-3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor

Drug Facts

Other Information
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF).

keep tightly closed.

Inactive Ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener 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. (1-800-222-1222)

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 lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity) 
  • generally produces bowel movement in 12 to 72 hours
Section 51945-4 (51945-4)

PHARBEST

NDC 16103-0399-11

*Compare to the active ingredient of Colace ®

Docusate

Sodium

Stool Softener

1000 SOFTGELS

100 mg each

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

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

Purpose

Stool softener

Warnings

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Directions
  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over                  take 1-3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor

Drug Facts

Other Information (Other information)
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF).

keep tightly closed.

Inactive Ingredients (Inactive ingredients)

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener 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. (1-800-222-1222)

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 lasts over 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.458684 · Updated: 2026-03-14T23:14:06.332069