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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

Purpose

Stool Softener Laxative

Description

Docusate Sodium 100 mg


Medication Information

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.

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

Stool Softener Laxative

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

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.

Description

Docusate Sodium 100 mg

Section 50565-1

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

Package Label

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg


Structured Label Content

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.

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

Stool Softener Laxative

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

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.

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.

Package Label

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

Docusate Sodium 100 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)