424 - Stool Softener

424 - Stool Softener
SPL v2
SPL
SPL Set ID 64266195-1b07-42c2-98a7-d76c12f74776
Route
ORAL
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-06-18 Until 2025-08-04

Description

Docusate sodium 100mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 100mg

Use(s)
  •  relieves occasional constipation (irregularity)
  •  generally produces bowel movement in 12 to 72 hours
Directions

Take only by mouth.

Adults and children 12 years and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

Children 2 to under 12 years of age: take 1 softgel daily

Children under 2 years of age: ask a doctor

Do Not Use
  • if you are presently taking mineral oil, unless told to do so by a doctor
Other Information
  • each softgel contains: sodium 5mg
  • VERY LOW SODIUM
  • do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature 15°-30°C (59°-86°F), protect from excessive humidity.
Questions/comments

Call 1-888-952-0050 Monday to Friday 9am-5pm

Active Ingredient(s)

Docusate sodium 100mg

Inactive Ingredients

Anhydrous citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,

propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

Principal Display Panel
Stool Softener
Ask A Doctor Before Use If
  • stomach pain
  • nausea
  • vomiting
  • notice a sudden change in bowel habits that lasts over 2 weeks
Stop Use and Ask A Doctor If
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need a laxative for more than 1 week
If Pregnant Or Breastfeeding,

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 (1-800-222-1222) right away.


Structured Label Content

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

Stool softener

Directions

Take only by mouth.

Adults and children 12 years and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

Children 2 to under 12 years of age: take 1 softgel daily

Children under 2 years of age: ask a doctor

Do Not Use (Do not use)
  • if you are presently taking mineral oil, unless told to do so by a doctor
Other Information (Other information)
  • each softgel contains: sodium 5mg
  • VERY LOW SODIUM
  • do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature 15°-30°C (59°-86°F), protect from excessive humidity.
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday to Friday 9am-5pm

Active Ingredient(s) (Active ingredient(s))

Docusate sodium 100mg

Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,

propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

Principal Display Panel
Stool Softener
Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach pain
  • nausea
  • vomiting
  • notice a sudden change in bowel habits that lasts over 2 weeks
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need a laxative for more than 1 week
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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