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

Active Ingredient

Active ingredient (in each softgel)

Docusate sodium USP 50 mg

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 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

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each softgel)

Docusate sodium USP 50 mg

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

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 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

All Sections (JSON)