Docusate Sodium Softgels

SPL v2

SPL

SPL Set ID 05b0732b-012f-78ee-e063-6294a90a839a

Route

ORAL

Published

Effective Date 2023-09-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Gelatin Glycerin Sorbitol Sorbitan Fd&c Yellow No. 6 Water Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance

Imprint: AD2 Shape: oval Color: red Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-25

Description

Active Ingredient (In each softgel) Docusate Sodium.... 100 mg

Medication Information

Warnings and Precautions

Warnings

Do not use

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

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

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 a signs of a serious condition.
you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Indications and Usage

Uses

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

Dosage and Administration

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 to 3 softgels daily

children 2 to under 12 years of age : take 1 softgel daily

children under 2 years : ask a doctor

Description

Active Ingredient (In each softgel) Docusate Sodium.... 100 mg

Section 42229-5

Compare to the active ingredient in Colace® Regular Strength Stool Softener†

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

Section 44425-7

Other Information

each softgel contains: sodium 5 mg

store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink

Section 51945-4

NDC 24689-130-01

Docusate Sodium 100mg

Stool Softener Laxative

MADE IN USA

100 Softgels

Section 53413-1

Questions or Comments ?

Call 1-855-642-2594

Section 55105-1

Purpose

Stool softener laxative

Section 55106-9

Active Ingredient (In each softgel)

Docusate Sodium.... 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

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 to 3 softgels daily

children 2 to under 12 years of age : take 1 softgel daily

children under 2 years : ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use

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

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

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 a signs of a serious condition.
you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Section 42229-5 (42229-5)

Compare to the active ingredient in Colace® Regular Strength Stool Softener†

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

Section 44425-7 (44425-7)

Other Information

each softgel contains: sodium 5 mg

store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink

Section 51945-4 (51945-4)

NDC 24689-130-01

Docusate Sodium 100mg

Stool Softener Laxative

MADE IN USA

100 Softgels

Section 53413-1 (53413-1)

Questions or Comments ?

Call 1-855-642-2594

Section 55105-1 (55105-1)

Purpose

Stool softener laxative

Section 55106-9 (55106-9)

Active Ingredient (In each softgel)

Docusate Sodium.... 100 mg

Advanced Ingredient Data

[{"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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"}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "34068-7": "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 to 3 softgels daily children 2 to under 12 years of age : take 1 softgel daily children under 2 years : ask a doctor", "34071-1": "Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that last over 2 weeks 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 a signs of a serious condition. you need to use a stool softner laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use.", "42229-5": "Compare to the active ingredient in Colace® Regular Strength Stool Softener† †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener. Rev.: 03/2023 Manufactured by: Apnar Pharma LLP East Windsor, NJ 08520", "44425-7": "Other Information each softgel contains: sodium 5 mg store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "51727-6": "Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink", "51945-4": "NDC 24689-130-01 Docusate Sodium 100mg Stool Softener Laxative MADE IN USA 100 Softgels", "53413-1": "Questions or Comments ? Call 1-855-642-2594", "55105-1": "Purpose Stool softener laxative", "55106-9": "Active Ingredient (In each softgel) Docusate Sodium.... 100 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:17.228002 · Updated: 2026-03-14T23:06:51.816479