Docusate Sodium 100 Mg Softgels

Docusate Sodium 100 Mg Softgels
SPL v19
SPL
SPL Set ID 66ca7a94-378b-4476-8060-d9c6f82f57fc
Route
ORAL
Published
Effective Date 2019-03-25
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, Unspecified Glycerin Polyethylene Glycol, Unspecified Water Sorbitol Titanium Dioxide D&c Red No. 33

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

Docusate

Sodium

Warnings

Do not use if you are presently taking mineral oil, unless directed 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 of age ask a doctor

Questions?

Adverse drug event call:(866) 562-2756 Mon-Fri 8 AM to 4 PM

Other Information
  • Tamper Evident: Do not use if seal is broken or missing from bottle
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25 oC (77 oF); excursions permitted between 15 o-30 oC (59 o-86 oF).

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 

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 or 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)

Docusate

Sodium

Purpose

Stool softener

Warnings

Do not use if you are presently taking mineral oil, unless directed 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 of age ask a doctor

Questions?

Adverse drug event call:(866) 562-2756 Mon-Fri 8 AM to 4 PM

Other Information (Other information)
  • Tamper Evident: Do not use if seal is broken or missing from bottle
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25 oC (77 oF); excursions permitted between 15 o-30 oC (59 o-86 oF).

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 

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 or 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: 2026-02-15T12:02:51.772946 · Updated: 2026-03-14T23:13:06.603726