Cvs 651t Docusate Sodium 50mg Softgel (red)

Cvs 651t Docusate Sodium 50mg Softgel (red)
SPL v2
SPL
SPL Set ID 273e5b52-1cf9-2525-e063-6394a90a8b4f
Route
ORAL
Published
Effective Date 2025-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Noncrystallizing Sorbitol Solution Titanium Dioxide Gelatin Water Polyethylene Glycol, Unspecified Shellac Fd&c Blue No. 1 D&c Red No. 33 Propylene Glycol Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: 164 Shape: oval Color: red Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

Active ingredient (in each softgel) Docusate sodium USP 50 mg


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 1-6 softgels daily

children 2 to

under 12 years of age
take 1-3 softgels daily
children under 2 years ask a doctor

Description

Active ingredient (in each softgel) Docusate sodium USP 50 mg

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 33, FD&C blue 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

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 50 mg

Section 60561-8

Other information

  • each softgel contains: sodium 3 mg VERY LOW SODIUM
  • Keep tightly closed. Store at 25°C (77°F); excursions permitted between 15°-30°C (59-86°F)

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 1-6 softgels daily

children 2 to

under 12 years of age
take 1-3 softgels 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 33, FD&C blue 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

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 50 mg

Section 60561-8 (60561-8)

Other information

  • each softgel contains: sodium 3 mg VERY LOW SODIUM
  • Keep tightly closed. Store at 25°C (77°F); excursions permitted between 15°-30°C (59-86°F)

Advanced Ingredient Data


Raw Label Data

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