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

Description

Docusate sodium 100 mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Pr

Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours
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
Do Not Use
  • if you are presently taking mineral oil, unless directed by a doctor
Questions?

Call 1-866-255-6960

Active Ingredient

Docusate sodium 100 mg

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

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

Pr

Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

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

Call 1-866-255-6960

Active Ingredient (Active ingredient)

Docusate sodium 100 mg

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

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

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