730t- Target-docusate Sodium 100mg - Dual Color

730t- Target-docusate Sodium 100mg - Dual Color
SPL v3
SPL
SPL Set ID 28fce2e2-2101-df88-e063-6394a90aa3de
Route
ORAL
Published
Effective Date 2025-04-30
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 Gelatin Glycerin Polyethylene Glycol 400 Water Sorbitol Solution Titanium Dioxide Ferrosoferric Oxide Fd&c Blue No. 1 Fd&c Yellow No. 6 Shellac Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: 102 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-25

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:

  • 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

Description

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 (1-800-222-1222).

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 a stool softener laxative for more than 1 week
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 told to do so by a doctor
Section 51727-6

Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 53414-9

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

Section 55105-1

Purpose

Stool softener

Section 55106-9

Active ingredient (in each softgel)

Docusate sodium USP 100 mg

Section 60561-8

Other information

  • each capsule contains: sodium 6 mg
  • keep tightly closed.
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Drug Facts

Drug Facts


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:

  • 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

Warnings and Precautions (34071-1)

Warnings

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 (1-800-222-1222).

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 a stool softener laxative for more than 1 week
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 told to do so by a doctor
Section 51727-6 (51727-6)

Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stool softener

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Docusate sodium USP 100 mg

Section 60561-8 (60561-8)

Other information

  • each capsule contains: sodium 6 mg
  • keep tightly closed.
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Drug Facts

Drug Facts


Advanced Ingredient Data


Raw Label Data

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