fleet oral lax docusate sodium 0132-0402

fleet oral lax docusate sodium 0132-0402
SPL v2
SPL
SPL Set ID 56a7b6c5-d674-4eed-91c2-77f7d18fff32
Route
oral
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
citric acid monohydrate d&c red no. 33 fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 glycerin gelatin polyethylene glycol, unspecified sorbitol solution water propylene glycol

Identifiers & Packaging

Pill Appearance
Imprint: PC18 Shape: oval Color: red Color: white Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-06-21

Purpose

Stool softener

Description

Docusate sodium 100 mg


Medication Information

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener

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 softgels daily
Children 2 to under 12 years of age take 1 softgel daily
Children under 2 years ask a doctor
Other Information
  • each softgel contains: sodium 5 mg

  • VERY LOW SODIUM

  • store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)
Inactive Ingredients

black edible ink, citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol solution, water

Description

Docusate sodium 100 mg

Questions?

Call 1-866-255-6960

Pr

Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

Do Not Use
  • if you are presently taking mineral oil, unless directed by a doctor
Active Ingredient

Docusate sodium 100 mg

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These symptoms may indicate a serious condition.

  • you need to use a stool softener laxative for more than 1 week
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • abdominal pain

  • nausea

  • vomiting

  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener

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 softgels daily
Children 2 to under 12 years of age take 1 softgel daily
Children under 2 years ask a doctor
Other Information (Other information)
  • each softgel contains: sodium 5 mg

  • VERY LOW SODIUM

  • store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)
Inactive Ingredients (Inactive ingredients)

black edible ink, citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol solution, water

Questions?

Call 1-866-255-6960

Pr

Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

Do Not Use (Do not use)
  • if you are presently taking mineral oil, unless directed by a doctor
Active Ingredient (Active ingredient)

Docusate sodium 100 mg

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 symptoms may indicate a serious condition.

  • you need to use a stool softener laxative for more than 1 week
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain

  • nausea

  • vomiting

  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)