Fos 421

Fos 421
SPL v2
SPL
SPL Set ID ff2179bd-cc76-9ee9-e053-6294a90a01c9
Route
ORAL
Published
Effective Date 2016-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Stearic Acid Croscarmellose Sodium Microcrystalline Cellulose Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Silicon Dioxide Talc Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Imprint: GC422 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01
Description

Docusate Sodium 100 mg

Purpose

Stool Softener

Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 100 mg

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

Ask a doctor before use if you

  • have stomach pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

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

Directions

  • adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses.
  • children under 12: ask a doctor
  • do not exceed recommended dose
Package Label

Active Ingredient

Docusate Sodium 100 mg

Other Information
  • each tablet contains: calcium 50 mg, sodium 10 mg
  • store at room temperature 15°C-30°C (59°F-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid, talc

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Keep Out of Reach of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

Structured Label Content

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

Stool Softener

Warnings

Ask a doctor before use if you

  • have stomach pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

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

Directions

  • adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses.
  • children under 12: ask a doctor
  • do not exceed recommended dose
Package Label (PACKAGE LABEL)

Active Ingredient (Active ingredient)

Docusate Sodium 100 mg

Other Information (Other information)
  • each tablet contains: calcium 50 mg, sodium 10 mg
  • store at room temperature 15°C-30°C (59°F-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid, talc

Questions Or Comments? (Questions or comments?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

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

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.594482 · Updated: 2026-03-14T23:01:28.904310