docusate sodium capsules usp 100 mg

SPL v1

SPL

SPL Set ID 20b96ed4-bb79-445c-e063-6394a90ae81a

Route

oral

Published

Effective Date 2024-08-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

docusate (100 mg)

Inactive Ingredients

sorbitol polyethylene glycol 400 water fd&c red no. 40 propylene glycol gelatin fd&c yellow no. 6 glycerin

Identifiers & Packaging

Pill Appearance

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

Marketing Status

otc monograph drug active Since 2024-08-31

Purpose

Stool softener

Description

Docusate Sodium USP 100 mg

Medication Information

Warnings

Do not use

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

Uses

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

Purpose

Stool softener

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 1-3 capsules daily
children 2 to under 12 years of age	take 1 capsule daily
children under 2 years	ask a doctor

Other Information

each softgel contains: Sodium 5 mg
store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F).

Keep tightly closed.

Description

Docusate Sodium USP 100 mg

Principal Display Panel

Tamper Evident

Do not use if safety seal under cap is broken or missing

Manufactured By

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1,

Vandalur-Kelambakkam Road,

Pudupakkam Village,

Kancheepuram District,

Tamilnadu - 603 103, India.

Mfg. Lic. No.: XXXXXXXXXXXX

Inactive Ingredient

FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan solution, water.

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Docusate Sodium USP 100 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Warnings

Do not use

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

Uses

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

Purpose

Stool softener

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 1-3 capsules daily
children 2 to under 12 years of age	take 1 capsule daily
children under 2 years	ask a doctor

Other Information (Other information)

each softgel contains: Sodium 5 mg
store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F).

Keep tightly closed.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Tamper Evident (TAMPER EVIDENT)

Do not use if safety seal under cap is broken or missing

Manufactured By (Manufactured by)

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1,

Vandalur-Kelambakkam Road,

Pudupakkam Village,

Kancheepuram District,

Tamilnadu - 603 103, India.

Mfg. Lic. No.: XXXXXXXXXXXX

Inactive Ingredient (Inactive ingredient)

FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan solution, water.

Stop Use and Ask A Doctor If (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 signs of a serious condition.
you need to use a stool softener laxative for more than 1 week

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium USP 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "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": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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", "Warnings": "Do not use if you are presently taking mineral oil, unless told to do so by a doctor", "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 1-3 capsules daily children 2 to under 12 years of age take 1 capsule daily children under 2 years ask a doctor", "TAMPER EVIDENT": "Do not use if safety seal under cap is broken or missing", "Manufactured by": "Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam Village, Kancheepuram District, Tamilnadu - 603 103, India. Mfg. Lic. No.: XXXXXXXXXXXX", "Other information": "each softgel contains: Sodium 5 mg store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F). Keep tightly closed.", "Inactive ingredient": "FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan solution, water.", "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 signs of a serious condition. you need to use a stool softener laxative for more than 1 week", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each softgel)": "Docusate Sodium USP 100 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that last over 2 weeks"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.461815 · Updated: 2026-03-14T23:03:36.040902