Rel 401

Rel 401
SPL v1
SPL
SPL Set ID 44fae161-3fc8-64c4-e063-6294a90a1d26
Route
ORAL
Published
Effective Date 2013-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Sorbitol Water Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01
Description

Docusate Sodium 100 mg

Purpose

Stool Softener

Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 50565-1

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

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that lasts for over 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
  • do not exceed recommended dose
  • take only by mouth
  • adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor.
  • children under 12: ask a doctor
Package Label

Other Information

• each softgel contains: sodium 7 mg. Very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

• Tamper Evident: Do not use if imprinted seal

under cap is missing or broken.

Inactive Ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, sorbitol special, purified water.

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 50565-1 (50565-1)

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

Purpose

Stool Softener

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that lasts for over 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
  • do not exceed recommended dose
  • take only by mouth
  • adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor.
  • children under 12: ask a doctor
Package Label

Other Information (Other information)

• each softgel contains: sodium 7 mg. Very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

• Tamper Evident: Do not use if imprinted seal

under cap is missing or broken.

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, sorbitol special, purified water.

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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

Docusate Sodium 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.896364 · Updated: 2026-03-14T23:10:51.714911