drug facts

drug facts

SPL v4

SPL

SPL Set ID 1bf34386-f065-4334-b5ca-1691f509946d

Route

oral

Published

Effective Date 2017-08-28

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 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: 50436-0399 NDC: 50436-0399-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

Description

Docusate sodium 100 mg

Medication Information

Warnings

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 capsule contains: sodium 6 mg
VERY LOW SODIUM
store at 25°C (77°F); excursions permitted between 15^o-30^oC (59^o-86^oF).

Keep tightly closed.

This Package for Households Without Young Children

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: 50436-0399

NDC: 50436-0399-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

Description

Docusate sodium 100 mg

Questions?

Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Do Not Use

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

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

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

Stool Softner (docusate Sodium ) Capsule, Liquid Filled

Structured Label Content

Warnings

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 capsule contains: sodium 6 mg
VERY LOW SODIUM
store at 25°C (77°F); excursions permitted between 15^o-30^oC (59^o-86^oF).

Keep tightly closed.

This Package for Households Without Young Children

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: 50436-0399

NDC: 50436-0399-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

Questions?

Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Do Not Use (Do not use)

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

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

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

Stool Softner (docusate Sodium ) Capsule, Liquid Filled (STOOL SOFTNER (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED)

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": "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", "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", "Questions?": "Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM * This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.", "HOW SUPPLIED": "Product: 50436-0399 NDC: 50436-0399-1 30 CAPSULE, LIQUID FILLED in a BOTTLE", "Other information": "Tamper Evident: do not use if safety seal under cap is broken or missing each capsule contains: sodium 6 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15 o -30 o C (59 o -86 o F). Keep tightly closed. This Package for Households Without Young Children ", "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 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", "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: 2026-02-15T11:56:24.258506 · Updated: 2026-03-14T22:54:50.171645