Docusate Sodium 100 Mg

Docusate Sodium 100 Mg
SPL v4
SPL
SPL Set ID 597bab7a-3b62-1083-e053-2a91aa0a9d48
Route
ORAL
Published
Effective Date 2017-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Water Sorbitol Polyethylene Glycol 400 Fd&c Red No. 40 Glycerin Food Yellow 3 Free Acid Gelatin

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-03-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Dosage and Administration

Directions

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • each softgel contains: s odium 7 mg
  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat
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 a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use stool softner 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 50570-1

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

Section 51727-6

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

Section 51945-4

NDC 69618-044-10

*Compare to the active ingredient in Colace®

Reliable-1™ LABORATORIES

Docusate Sodium 100 mg

STOOL SOFTENER LAXATIVE

1000 SOFTGELS

Section 53413-1

Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

Section 53414-9

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

Section 55105-1

Purpose

Stool softener laxative

Section 55106-9

Active ingredient (in each softgel)

Docusate sodium 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • each softgel contains: s odium 7 mg
  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat
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 a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use stool softner 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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

Section 51945-4 (51945-4)

NDC 69618-044-10

*Compare to the active ingredient in Colace®

Reliable-1™ LABORATORIES

Docusate Sodium 100 mg

STOOL SOFTENER LAXATIVE

1000 SOFTGELS

Section 53413-1 (53413-1)

Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stool softener laxative

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Docusate sodium 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:18.005836 · Updated: 2026-03-14T23:00:41.107943