420-stool Softener

SPL v7

SPL

SPL Set ID 909cd222-d836-416f-aa7d-deb4a0c5a560

Route

ORAL

Published

Effective Date 2020-09-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 400 Propylene Glycol Sorbitol Solution Water

Identifiers & Packaging

Pill Appearance

Imprint: PC18 Shape: capsule Color: red Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-04-10

Description

Docusate sodium 100mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100mg

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 capsules daily

Children 2 to under 12 years of age: take 1 capsule daily

Children under 2 years of age: ask a doctor

Use(s)

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

Storage

store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Questions

Call 1-888-952-0050 Monday through

Friday 9am-5pm

Do Not Use

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

Other Information

each capsule contains: sodium 5mg
VERY LOW SODIUM

Active Ingredient(s)

Docusate sodium 100mg

Inactive Ingredients

black edible ink, citric acid, 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 special

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Stool Softener

Ask A Doctor Before Use If

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

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

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

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 capsules daily

Children 2 to under 12 years of age: take 1 capsule daily

Children under 2 years of age: ask a doctor

Use(s)

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

Purpose

Stool softener

Storage

store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Questions

Call 1-888-952-0050 Monday through

Friday 9am-5pm

Do Not Use (Do not use)

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

Other Information (Other information)

each capsule contains: sodium 5mg
VERY LOW SODIUM

Active Ingredient(s) (Active ingredient(s))

Docusate sodium 100mg

Inactive Ingredients (Inactive ingredients)

black edible ink, citric acid, 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 special

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Stool Softener

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{" ": "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 capsules daily Children 2 to under 12 years of age: take 1 capsule daily Children under 2 years of age: ask a doctor", "Use(s)": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "Purpose": "Stool softener", "Storage": "store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)", "Questions": "Call 1-888-952-0050 Monday through Friday 9am-5pm", "Do not use": " if you are presently taking mineral oil, unless told to do so by a doctor", "Other information": "each capsule contains: sodium 5mg VERY LOW SODIUM", "Active ingredient(s)": "Docusate sodium 100mg", "Inactive ingredients": "black edible ink, citric acid, 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 special", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": "Stool Softener", "Ask a doctor before use if": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks", "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", "Keep out of reach of children": "In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:25.947536 · Updated: 2026-03-14T23:01:24.251815