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
Purpose

Stool softener

Description

Docusate Sodium 100 mg

Medication Information

Warnings

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

Uses
  • relieves occasional constipation (irregularity) 
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener

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

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 

Description

Docusate Sodium 100 mg

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

Drug Facts

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

Warnings

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

Uses
  • relieves occasional constipation (irregularity) 
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener

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

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 

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

Drug Facts

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