Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID e5d7f7e7-c091-4546-9076-7672b1b7b7a8

Route

ORAL

Published

Effective Date 2021-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Sorbitan Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Glycerin Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance

Imprint: P51;S77;SCU1;D2 Shape: oval Color: orange Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-02-28

Description

Docusate Sodium 100 mg

Purpose

Stool softener laxative

How Supplied

Product: 50090-5268 NDC: 50090-5268-0 20 CAPSULE in a BOTTLE NDC: 50090-5268-1 100 CAPSULE in a BOTTLE NDC: 50090-5268-2 60 CAPSULE in a BOTTLE

Medication Information

Purpose

Stool softener laxative

How Supplied

Product: 50090-5268

NDC: 50090-5268-0 20 CAPSULE in a BOTTLE

NDC: 50090-5268-1 100 CAPSULE in a BOTTLE

NDC: 50090-5268-2 60 CAPSULE in a BOTTLE

Description

Docusate Sodium 100 mg

Uses

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

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 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 6 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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 a signs of a serious condition.
you need to use a laxative for more than 1 week

Dok (docusate Sodium) Capsule

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 last over 2 weeks

Structured Label Content

Uses

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

Purpose

Stool softener laxative

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 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 (Do not use)

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

How Supplied (HOW SUPPLIED)

Product: 50090-5268

NDC: 50090-5268-0 20 CAPSULE in a BOTTLE

NDC: 50090-5268-1 100 CAPSULE in a BOTTLE

NDC: 50090-5268-2 60 CAPSULE in a BOTTLE

Other Information (Other information)

each softgel contains: sodium 6 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients (Inactive ingredients)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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 a signs of a serious condition.
you need to use a laxative for more than 1 week

Dok (docusate Sodium) Capsule (DOK (DOCUSATE SODIUM) CAPSULE)

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

In case of overdose, get medical help or contact a Poison Control Center right away.

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 last over 2 weeks

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "Purpose": "Stool softener laxative", "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 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.", "HOW SUPPLIED": "Product: 50090-5268 NDC: 50090-5268-0 20 CAPSULE in a BOTTLE NDC: 50090-5268-1 100 CAPSULE in a BOTTLE NDC: 50090-5268-2 60 CAPSULE in a BOTTLE", "Other information": "each softgel contains: sodium 6 mg store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)", "Inactive ingredients": "edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol *contains one or more of these ingredients", "Questions or comments?": " Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "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 a signs of a serious condition. you need to use a laxative for more than 1 week", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "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 last over 2 weeks"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:26.488486 · Updated: 2026-03-14T22:59:25.623456