Docusate Sodium 100 Mg

Docusate Sodium 100 Mg
SPL v3
SPL
SPL Set ID 383ce892-de63-62e8-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2019-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Anhydrous Citric Acid Fd&c Red No. 40 Fd&c Blue No. 1 Fd&c Yellow No. 6 Water Sorbitol Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-04-01
Description

Drug Facts

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Drug Facts

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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 sings of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8
  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Warnings

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

Directions
adults and children 12 years and over take 1 -3 softgels once daily or in divided doses
children 2 to under 12 years of age 1 softgel once daily
children under 2 years ask a doctor

Inactive Ingredients

citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments ?

Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Principline Display Panel Bottle Label 100ct

NDC 69618-043-01

Docusate Sodium 100 mg 100 SOFTGELS

STOOL SOFTENER LAXATIVE

Principline Display Panel Bottle Label 1000ct

NDC 69618-043-10

Docusate Sodium 100 mg 1000 SOFTGELS

STOOL SOFTENER LAXATIVE

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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 sings of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8 (60561-8)
  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Purpose

Stool softener laxative

Warnings

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

Directions
adults and children 12 years and over take 1 -3 softgels once daily or in divided doses
children 2 to under 12 years of age 1 softgel once daily
children under 2 years ask a doctor

Inactive Ingredients (Inactive ingredients)

citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments ? (Questions or comments ?)

Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Principline Display Panel Bottle Label 100ct (PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct)

NDC 69618-043-01

Docusate Sodium 100 mg 100 SOFTGELS

STOOL SOFTENER LAXATIVE

Principline Display Panel Bottle Label 1000ct (PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct)

NDC 69618-043-10

Docusate Sodium 100 mg 1000 SOFTGELS

STOOL SOFTENER LAXATIVE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:56.452729 · Updated: 2026-03-14T22:55:45.140912