Gentle Stool Softener

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Water Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 100 Shape: oval Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-07

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 12–72 hours

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 50568-5

Ask a doctor or pharmacist before use if you are if you have

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

Section 50569-3

Ask a doctor before use if you have • fever • mucus in the stool

Section 50570-1

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Section 53414-9

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

Directions

• take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults & children 12 years of age & over	take 1–3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years of age	ask a doctor

Drug Facts

Other Information

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed

Principal Display

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Tablet)

Docusate sodium 100 mg

Structured Label Content

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 12–72 hours

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are if you have

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have • fever • mucus in the stool

Section 50570-1 (50570-1)

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Section 53414-9 (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 & children 12 years of age & over	take 1–3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years of age	ask a doctor

Drug Facts

Other Information (Other information)

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed

Principal Display

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Docusate sodium 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• relieves occasional constipation (irregularity) • generally produces bowel movement in 12–72 hours", "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)", "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", "50568-5": "Ask a doctor or pharmacist before use if you are if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks", "50569-3": "Ask a doctor before use if you have • fever • mucus in the stool", "50570-1": "Do not use if you are presently taking mineral oil, unless told to do so by a doctor", "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 & children 12 years of age & over take 1–3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor", "Other information": "• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed", "Inactive ingredients": "FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide", "Questions or comments?": "1-888-333-9792", "Active Ingredient (in each tablet)": "Docusate sodium 100 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information