docusate sodium 100 mg softgels

docusate sodium 100 mg softgels
SPL v2
SPL
SPL Set ID 1b2f2afd-1e8a-058c-e063-6294a90a24ff
Route
oral
Published
Effective Date 2024-06-26
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 sorbitol titanium dioxide glycerin fd&c yellow no. 6 polyethylene glycol, unspecified water gelatin, unspecified

Identifiers & Packaging

Pill Appearance
Imprint: SCU2 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-10-01
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

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
Package Label Principal Display Panel

PHARMAMED

NDC 84289-399-01

Manufactured in the U.S.A

Docusate

Sodium

100 softgels

100mg each

*Compare to the active ingredient of Colace*

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

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

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

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
Package Label Principal Display Panel

PHARMAMED

NDC 84289-399-01

Manufactured in the U.S.A

Docusate

Sodium

100 softgels

100mg each

*Compare to the active ingredient of Colace*

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:38.371887 · Updated: 2026-03-14T23:03:49.531028