Stool Softener Docusate Sodium

SPL v5

SPL

SPL Set ID a0e6ab9b-fd31-45fd-93d5-b51d705c180a

Route

ORAL

Published

Effective Date 2017-04-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-04-04

Description

Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace * ® Effective, Gentle Stimulant Free For Comfortable Relief 1000 SOFTGELS

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace * ® Effective, Gentle Stimulant Free For Comfortable Relief 1000 SOFTGELS

Uses

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

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

ask a health professional before use. If pregnant or breast-feeding,

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

stomach pain
nausea
vomiting
noticed a sudden change in bowel movements that continues over a period of 2 weeks

you have rectal bleeding or you 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 for mroe than 1 week.

Directions

Take only by mouth. This dose may be taken as a single daily dose or in divided doses.
take 1-3 softgels daily or as directed by a doctor adults and children over 12 years of age:
take 1 softgel daily or as directed by a doctor children 2 to under 12 years of age:
ask a doctor children under 2 years of age:

Questions?

call toll-free 1-800-935-6737

Other Information

sodium 7mg each softgel contains:
store between 15° to 30°C (59° to 86°F)
Protect from moisture

Package Labeling:

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol.

Mhl Ndc 54257 902 06

Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace *

^®

Effective, Gentle Stimulant Free For Comfortable Relief

1000 SOFTGELS

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center ( ) right away. 1-800-222-1222

Active Ingredient (in Each Softgel)

Docusate sodium 100mg

*this Product Is Not Manufactured Or Distributed By the Owner of the Registered Trademark Colace®. Distributed By: Magno Humphries, Inc. Or 97223 U.s.a. visit Our Website: Www.magno Humphries.com

*This product is not manufactured or distributed by the owner of the registered trademark Colace®.

Distributed by: , OR 97223 U.S.A.

Magno-Humphries, Inc. Visit our website: www.magno-humphries.com

Structured Label Content

Uses

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

Purpose

Stool softener

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

ask a health professional before use. If pregnant or breast-feeding,

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

stomach pain
nausea
vomiting
noticed a sudden change in bowel movements that continues over a period of 2 weeks

you have rectal bleeding or you 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 for mroe than 1 week.

Directions

Take only by mouth. This dose may be taken as a single daily dose or in divided doses.
take 1-3 softgels daily or as directed by a doctor adults and children over 12 years of age:
take 1 softgel daily or as directed by a doctor children 2 to under 12 years of age:
ask a doctor children under 2 years of age:

Questions?

call toll-free 1-800-935-6737

Other Information (Other information)

sodium 7mg each softgel contains:
store between 15° to 30°C (59° to 86°F)
Protect from moisture

Package Labeling:

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol.

Mhl Ndc 54257 902 06 (MHL NDC 54257-902-06)

Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace *

^®

Effective, Gentle Stimulant Free For Comfortable Relief

1000 SOFTGELS

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental 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 100mg

*this Product Is Not Manufactured Or Distributed By the Owner of the Registered Trademark Colace®. Distributed By: Magno Humphries, Inc. Or 97223 U.s.a. visit Our Website: Www.magno Humphries.com (*This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: Magno-Humphries, Inc. OR 97223 U.S.A. Visit our website: www.magno-humphries.com)

*This product is not manufactured or distributed by the owner of the registered trademark Colace®.

Distributed by: , OR 97223 U.S.A.

Magno-Humphries, Inc. Visit our website: www.magno-humphries.com

Advanced Ingredient Data

[{"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces a bowel movement in 12-72 hours", "Purpose": "Stool softener", "Warnings": "Do not use Ask a doctor before use if you have Stop use and ask a doctor if ask a health professional before use. If pregnant or breast-feeding, if you are presently taking mineral oil, unless told by a doctor stomach pain nausea vomiting noticed a sudden change in bowel movements that continues over a period of 2 weeks you have rectal bleeding or you 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 for mroe than 1 week.", "Directions": "Take only by mouth. This dose may be taken as a single daily dose or in divided doses. take 1-3 softgels daily or as directed by a doctor adults and children over 12 years of age: take 1 softgel daily or as directed by a doctor children 2 to under 12 years of age: ask a doctor children under 2 years of age:", "Questions?": "call toll-free 1-800-935-6737", "Other information": "sodium 7mg each softgel contains: store between 15° to 30°C (59° to 86°F) Protect from moisture", "Inactive ingredients": "FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol.", "MHL NDC 54257-902-06": "Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace * ® Effective, Gentle Stimulant Free For Comfortable Relief 1000 SOFTGELS", "Keep out of reach of children.": "In case of accidental overdose, get medical help or contact a Poison Control Center ( ) right away. 1-800-222-1222", "Active ingredient (in each softgel)": "Docusate sodium 100mg", "*This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: Magno-Humphries, Inc. OR 97223 U.S.A. Visit our website: www.magno-humphries.com": "*This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: , OR 97223 U.S.A. Magno-Humphries, Inc. Visit our website: www.magno-humphries.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:09.390334 · Updated: 2026-03-14T23:01:35.007581