Clear Stool Softener Clear

Clear Stool Softener Clear
SPL v4
SPL
SPL Set ID 5219895f-e407-485f-813c-0414002d4a49
Route
ORAL
Published
Effective Date 2023-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Povidone K30 Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: S50 Shape: oval Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-06

Description

Drug Facts

Purpose

Stool softener


Medication Information

Purpose

Stool softener

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. 1-800-222-1222

Section 50568-5

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

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 51945-4

Compare to the

active ingredient

in Colace® Clear*

Clear Stool Softener

DOCUSATE SODIUM, 50 mg

Section 53413-1

Questions or comments? 1-888-333-9792

Section 53414-9

If pregnant or breast-feeding, ask a health professional

before use.

Warnings

Do not use

■ if you are presently taking mineral oil, unless told to do

so by a doctor

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 to 6 softgels

daily
children 2 to under 12 years

of age
take 1 to 3 softgels

daily
children under 2 years ask a doctor

Active Ingredient

Docusate sodium 50 mg

Other Information

each softgel contains: sodium 0.02 mg 



■ store at 25°C (77°F); excursions permitted between

15°-30°C (59°-86°F). 

Inactive Ingredients

gelatin, glycerin, polyethylene glycol-400, povidone

(PVP K-30), propylene glycol, purified water, sorbitol

solution


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. 1-800-222-1222

Section 50568-5 (50568-5)

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)

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 51945-4 (51945-4)

Compare to the

active ingredient

in Colace® Clear*

Clear Stool Softener

DOCUSATE SODIUM, 50 mg

Section 53413-1 (53413-1)

Questions or comments? 1-888-333-9792

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional

before use.

Purpose

Stool softener

Warnings

Do not use

■ if you are presently taking mineral oil, unless told to do

so by a doctor

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 to 6 softgels

daily
children 2 to under 12 years

of age
take 1 to 3 softgels

daily
children under 2 years ask a doctor

Active Ingredient (Active ingredient)

Docusate sodium 50 mg

Other Information (Other information)

each softgel contains: sodium 0.02 mg 



■ store at 25°C (77°F); excursions permitted between

15°-30°C (59°-86°F). 

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol-400, povidone

(PVP K-30), propylene glycol, purified water, sorbitol

solution


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)