Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID f9ac0344-5864-4ac1-81bc-16878a5946c5

Route

ORAL

Published

Effective Date 2024-02-01

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 Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-09-15

Description

Docusate sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses

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

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

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

Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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

Structured Label Content

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 (Do not use)

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

Questions?

Adverse drug event call (800) 687-0176

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

Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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

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": "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", "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", "Principal Display Panel": "Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320", "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: 2026-02-15T12:02:47.656188 · Updated: 2026-03-14T23:02:32.213463