420-stool Softener

420-stool Softener
SPL v8
SPL
SPL Set ID 30c9ff75-cee4-4632-86fd-acfdf5ee85af
Route
ORAL
Published
Effective Date 2020-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Anhydrous 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 400 Propylene Glycol Sorbitol Solution Water

Identifiers & Packaging

Pill Appearance
Imprint: PC18 Shape: capsule Color: red Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-04-10

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

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

Call 1-888-952-0050 Monday through

Friday 9am-5pm

Directions
  • Take only by mouth.

Adults and children 12 years and over: take 1-3 softgels, daily. Doses 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: 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.



Active Ingredient(s)

Docusate sodium 100mg

Inactive Ingredients

black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C

yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water,

sorbitol special



Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Stool Softener


Ask A Doctor Before Use If

you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These could be signs of a serious condition.

  • you need to use a stool softener laxative for more than 1 week



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

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

Call 1-888-952-0050 Monday through

Friday 9am-5pm

Directions
  • Take only by mouth.

Adults and children 12 years and over: take 1-3 softgels, daily. Doses 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: 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.



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

Docusate sodium 100mg

Inactive Ingredients (Inactive ingredients)

black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C

yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water,

sorbitol special



Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Stool Softener


Ask A Doctor Before Use If (Ask a doctor before use if)

you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

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 could be signs of a serious condition.

  • you need to use a stool softener laxative for more than 1 week



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

All Sections (JSON)