drug facts

drug facts

SPL v4

SPL

SPL Set ID 33586efa-a589-49d7-8913-9d4503bfbe1f

Route

oral

Published

Effective Date 2016-12-08

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 glycerin polyethylene glycols propylene glycol sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: 51A Shape: oval Color: red Size: 5 mm Score: 1

Marketing Status

otc monograph not final active Since 2010-09-15

Purpose

Stool softener

How Supplied

Product: 50436-1222 NDC: 50436-1222-1 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

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

Other Information

each capsule contains sodium 6 mg
store at room temperature 15^o-30^oC (59^o-86^oF)
Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

How Supplied

Product: 50436-1222

NDC: 50436-1222-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

Description

Docusate sodium 100 mg

Questions?

Adverse drug event call (800) 687-0176

Do Not Use

if you are currently taking mineral oil, unless directed by a doctor

Stop Use and Ask A Doctor If

you have rectal bleeding
you fail to have a bowel movement after use
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.

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

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

Docusate Sodium (docusate Sodium ) Capsule, Liquid Filled

Inactive Ingredients: D&c Red #33,edible Ink, Fd&c Red #40, Fd&c Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Propylene Glycol, Sorbitol Special

Structured Label Content

Warnings

Uses

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

Purpose

Stool softener

Directions

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

Other Information (Other information)

each capsule contains sodium 6 mg
store at room temperature 15^o-30^oC (59^o-86^oF)
Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

How Supplied (HOW SUPPLIED)

Product: 50436-1222

NDC: 50436-1222-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

Questions?

Adverse drug event call (800) 687-0176

Do Not Use (Do not use)

if you are currently taking mineral oil, unless directed by a doctor

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

you have rectal bleeding
you fail to have a bowel movement after use
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.

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 or vomiting
have noticed a sudden change in bowel habits that lasts over 2 weeks

Docusate Sodium (docusate Sodium ) Capsule, Liquid Filled (DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED)

Inactive Ingredients: D&c Red #33,edible Ink, Fd&c Red #40, Fd&c Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Propylene Glycol, Sorbitol Special (Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special)

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", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "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": "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 currently taking mineral oil, unless directed by a doctor", "Questions?": "Adverse drug event call (800) 687-0176", "HOW SUPPLIED": "Product: 50436-1222 NDC: 50436-1222-1 30 CAPSULE, LIQUID FILLED in a BOTTLE", "Other information": "each capsule contains sodium 6 mg store at room temperature 15 o -30 o C (59 o -86 o F) Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing", "Stop use and ask a doctor if": "you have rectal bleeding you fail to have a bowel movement after use 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.", "Active ingredient (in each softgel)": "Docusate sodium 100 mg", "Ask a doctor before use if you have": "stomach pain, nausea or vomiting have noticed a sudden change in bowel habits that lasts over 2 weeks"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:13.527123 · Updated: 2026-03-14T22:54:33.877898