stool softener

Drug Facts

Composition & Product

Active Ingredients

docusate (100 mg)

Inactive Ingredients

anhydrous citric acid d&c red no. 33 fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified propylene glycol water sorbitol sorbitan

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2018-02-12

Medication Information

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours.

Purpose

Stool softener

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

Other Information

each softgel contains: sodium 5 mg
VERY LOW SODIUM
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

anhydrous citric acid, black ink, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white dispersion G.B

Description

Drug Facts

Principal Display Panel

STOOL SOFTENER

DOCUSATE SODIUM 100mg 10 Softgels

Compare to the active ingredient in COLACE

NDC 51013-426-48

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.

Section 53414-9

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

Do Not Use

if you are presently taking mineral oil, unless told to do so by a doctor

Questions Or Comments?

Call toll free: 1-855-215-8180

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

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours.

Purpose

Stool softener

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

Other Information (Other information)

each softgel contains: sodium 5 mg
VERY LOW SODIUM
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, black ink, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white dispersion G.B

Principal Display Panel

STOOL SOFTENER

DOCUSATE SODIUM 100mg 10 Softgels

Compare to the active ingredient in COLACE

NDC 51013-426-48

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.

Section 53414-9 (53414-9)

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

Do Not Use (Do not use)

if you are presently taking mineral oil, unless told to do so by a doctor

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Stop Use and Ask A Doctor If (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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Stool softener", "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", "Do not use": "if you are presently taking mineral oil, unless told to do so by a doctor ", "Other information": "each softgel contains: sodium 5 mg VERY LOW SODIUM store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat ", "Inactive ingredients": "anhydrous citric acid, black ink, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white dispersion G.B", "Questions or comments?": "Call toll free: 1-855-215-8180", "Principal Display Panel": "STOOL SOFTENER DOCUSATE SODIUM 100mg 10 Softgels Compare to the active ingredient in COLACE NDC 51013-426-48", "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", "Active ingredient (in each softgel)": "Docusate sodium 100 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks "}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information