Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 8d71cd2c-a62b-4c40-8062-e9c986afb0b5

Route

ORAL

Published

Effective Date 2012-10-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Docusate (250 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycols Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: P20 Shape: capsule Color: orange Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2002-08-27

Description

Docusate Sodium 250mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate Sodium 250mg

Uses

for the prevention of dry, hard stools
for relief of occasional constipation.
this product generally produces a bowel movement within 12 to 72 hours.

Section 51945-4

Docusate Sodium 250 mg

Directions

adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: take as directed by a doctor

Product Labeling

MAJOR DOK™

Docusate Sodium 250 mg

Extra Strength Stool Softener

For use as a Stool Softener in treating & Avoiding Constipation

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Other Information

each softgel contains sodium 15mg
store at controlled room temperature 15^o - 30^o C (59^o- 86^o F)
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Warnings Do Not Use

if you are taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for more than 1 week, unless directed by a doctor

Questions Or Comments?

Adverse Drug Event Call: (800) 616-2471

Ask A Doctor Before Use If

you notice a sudden change in bowel habits that persists over a period of 2 weeks

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If

you have rectal bleeding
you fail to have a bowel movement after 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 250mg

Structured Label Content

Uses

for the prevention of dry, hard stools
for relief of occasional constipation.
this product generally produces a bowel movement within 12 to 72 hours.

Section 51945-4 (51945-4)

Docusate Sodium 250 mg

Purpose

Stool softener

Directions

adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: take as directed by a doctor

Product Labeling

MAJOR DOK™

Docusate Sodium 250 mg

Extra Strength Stool Softener

For use as a Stool Softener in treating & Avoiding Constipation

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Other Information (Other information)

each softgel contains sodium 15mg
store at controlled room temperature 15^o - 30^o C (59^o- 86^o F)
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Warnings Do Not Use (Warnings - Do not use)

if you are taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for more than 1 week, unless directed by a doctor

Questions Or Comments? (Questions or comments?)

Adverse Drug Event Call: (800) 616-2471

Ask A Doctor Before Use If (Ask a doctor before use if)

you notice a sudden change in bowel habits that persists over a period of 2 weeks

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

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

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 250mg

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "250", "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", "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the prevention of dry, hard stools for relief of occasional constipation. this product generally produces a bowel movement within 12 to 72 hours.", "51945-4": " Docusate Sodium 250 mg", "Purpose": "Stool softener", "Directions": "adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age : take as directed by a doctor", "Product Labeling": "MAJOR DOK™ Docusate Sodium 250 mg Extra Strength Stool Softener For use as a Stool Softener in treating & Avoiding Constipation Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150, USA Repacked by: H.J. Harkins Company, Inc. Grover Beach, CA 93433", "Other information": "each softgel contains sodium 15mg store at controlled room temperature 15 o - 30 o C (59 o - 86 o F) do not use if imprinted safety seal under cap is broken or missing", "Inactive Ingredients": "edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.", "Warnings - Do not use": "if you are taking mineral oil, unless directed by a doctor when abdominal pain, nausea, or vomiting are present for more than 1 week, unless directed by a doctor", "Questions or comments?": "Adverse Drug Event Call : (800) 616-2471", "Ask a doctor before use if": "you notice a sudden change in bowel habits that persists over a period of 2 weeks", "If pregnant or breastfeeding": "ask a health professional before use.", "Stop use and ask a doctor if": "you have rectal bleeding you fail to have a bowel movement after 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 250mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:32.547454 · Updated: 2026-03-14T22:53:18.854428