Gc 401

Gc 401
SPL v2
SPL
SPL Set ID ed20d198-e935-200e-e053-2a95a90a309b
Route
ORAL
Published
Effective Date 2024-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-01-01

Description

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative


Medication Information

Purpose

Stool Softener Laxative

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

• 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

• do not exceed recommended dose

• adults and children 12 years and older: take 1-3

softgels daily until first bowel movement; 1 softgel

daily thereafter, or as directed by a doctor

• children under 12: consult 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, glycerin, PEG, sorbitol special, water.

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 Laxative

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

• do not exceed recommended dose

• adults and children 12 years and older: take 1-3

softgels daily until first bowel movement; 1 softgel

daily thereafter, or as directed by a doctor

• children under 12: consult 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, glycerin, PEG, sorbitol special, water.

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

Docusate Sodium 100 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)