drug facts

drug facts
SPL v2
SPL
SPL Set ID f4671579-aed0-4f93-ab83-248e0d72b5b0
Route
oral
Published
Effective Date 2024-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-12-15

Purpose

Stool softener laxative

Description

Docusate sodium 100 mg


Medication Information

Uses
  • for temporary relief of occasional constipation and irregularity 
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • take with a glass of water
 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  ask a doctor
Other Information
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77º); excursions permitted between 15-30ºC (59º-86ºF)
Inactive Ingredients

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Description

Docusate sodium 100 mg

Principal Display Panel

Stool Softener

Docusate Sodium 100 mg

Stool softener laxative

  • Stimulant-free

Softgels

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Do Not Use

if you are presently taking mineral oil, unless directed by a doctor

Product Label
REXALL Stool Softener
Questions Or Comments?

Call toll free 1-866-4-REXALL

Stop Use and Ask A Doctor If
  • you have rectal bleeding or no bowel movement after using a laxative. These could be sign of a serious condition.
  • you need to use a laxative for more than 1 week
If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (188-222-1222) right away

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Structured Label Content

Uses
  • for temporary relief of occasional constipation and irregularity 
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • take with a glass of water
 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  ask a doctor
Other Information (Other information)
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77º); excursions permitted between 15-30ºC (59º-86ºF)
Inactive Ingredients (Inactive ingredients)

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Principal Display Panel

Stool Softener

Docusate Sodium 100 mg

Stool softener laxative

  • Stimulant-free

Softgels

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Do Not Use (Do not use)

if you are presently taking mineral oil, unless directed by a doctor

Product Label
REXALL Stool Softener
Questions Or Comments? (Questions or comments?)

Call toll free 1-866-4-REXALL

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or no bowel movement after using a laxative. These could be sign of a serious condition.
  • you need to use a laxative for more than 1 week
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

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

In case of overdose, get medical help or contact a Poison Control Center (188-222-1222) right away

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

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)