drug facts

drug facts

SPL v1

SPL

SPL Set ID 09376e58-c50a-4eda-ab2a-b980a4b65dc0

Route

oral

Published

Effective Date 2019-04-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

docusate (100 mg)

Inactive Ingredients

d&c red no. 33 fd&c red no. 40 fd&c yellow no. 6 gelatin, unspecified glycerin polyethylene glycol, unspecified water sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: SCU2 Shape: oval Color: red Size: 12 mm Score: 1

Marketing Status

otc monograph not final active Since 2016-03-01

Purpose

Stool softener

How Supplied

Product: 50090-2731 NDC: 50090-2731-1 100 CAPSULE in a BOTTLE NDC: 50090-2731-2 60 CAPSULE in a BOTTLE NDC: 50090-2731-4 30 CAPSULE in a BOTTLE NDC: 50090-2731-0 20 CAPSULE in a BOTTLE

Description

Docusate Sodium 100 mg

Medication Information

Warnings

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

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

Tamper Evident: Do not use if safety seal under cap is broken or missing
each softgel contains: sodium 6 mg
VERY LOW SODIUM
store at 25^oC (77^oF); excursions permitted between 15^o-30^oC (59^o-86^oF).

keep tightly closed.

Inactive Ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide

How Supplied

Product: 50090-2731

NDC: 50090-2731-1 100 CAPSULE in a BOTTLE

NDC: 50090-2731-2 60 CAPSULE in a BOTTLE

NDC: 50090-2731-4 30 CAPSULE in a BOTTLE

NDC: 50090-2731-0 20 CAPSULE in a BOTTLE

Description

Docusate Sodium 100 mg

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

Docusate Sodium 100mg

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have 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

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. (1-800-222-1222)

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

Warnings

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

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)

Tamper Evident: Do not use if safety seal under cap is broken or missing
each softgel contains: sodium 6 mg
VERY LOW SODIUM
store at 25^oC (77^oF); excursions permitted between 15^o-30^oC (59^o-86^oF).

keep tightly closed.

Inactive Ingredients (Inactive ingredients)

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide

How Supplied (HOW SUPPLIED)

Product: 50090-2731

NDC: 50090-2731-1 100 CAPSULE in a BOTTLE

NDC: 50090-2731-2 60 CAPSULE in a BOTTLE

NDC: 50090-2731-4 30 CAPSULE in a BOTTLE

NDC: 50090-2731-0 20 CAPSULE in a BOTTLE

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

Docusate Sodium 100mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or fail to have 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

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. (1-800-222-1222)

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

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "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", "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 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor", "Questions?": "Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM", "HOW SUPPLIED": "Product: 50090-2731 NDC: 50090-2731-1 100 CAPSULE in a BOTTLE NDC: 50090-2731-2 60 CAPSULE in a BOTTLE NDC: 50090-2731-4 30 CAPSULE in a BOTTLE NDC: 50090-2731-0 20 CAPSULE in a BOTTLE", "Other information": "Tamper Evident: Do not use if safety seal under cap is broken or missing each softgel contains: sodium 6 mg VERY LOW SODIUM store at 25 o C (77 o F); excursions permitted between 15 o -30 o C (59 o -86 o F). keep tightly closed.", "Inactive ingredients": "D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide ", "Stop use and ask a doctor if": "you have rectal bleeding or fail to have 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", "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. (1-800-222-1222)", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:49.548981 · Updated: 2026-03-14T22:55:34.309870