Docusate Sodium Capsules Usp 100 Mg

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
Description

Docusate Sodium USP 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate Sodium USP 100 mg

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

Principal Display Panel

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

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 (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

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.

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Raw Label Data

All Sections (JSON)

Additional Information

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