drug facts

drug facts
SPL v5
SPL
SPL Set ID 81edf0d8-b6f3-4b3a-85db-0108160756b1
Route
oral
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified propylene glycol water sorbitan sorbitol titanium dioxide d&c red no. 33 ferrosoferric oxide

Identifiers & Packaging

Pill Appearance
Imprint: P10 Shape: oval Color: red Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-04-30

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg


Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in12 to 72 hours
Purpose

Stool softener laxative

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 6 mg
  • store at 25C (77o F); excursions permitted between 15-30o C (59o- 86o F)
Inactive Ingredients

black iron oxide, D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Description

Docusate Sodium 100 mg

Principal Display Panel

COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT**

Stool Softener

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

Stool Softener Laxative

Gentle & Effective, 

Stimulant-free,

Relieves Constipation

SOFTGELS

**This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® Regular Strength Stool Softener.

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

DIST. BY MEIJER DISTRIBUTION, INC,

GRAND RAPIDS, MI 49544

Do Not Use

if you are presently taking mineral oil, unless told so by a doctor.

Product Label
MEIJER Stool Softener
Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

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

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in12 to 72 hours
Purpose

Stool softener laxative

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 6 mg
  • store at 25C (77o F); excursions permitted between 15-30o C (59o- 86o F)
Inactive Ingredients

black iron oxide, D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT**

Stool Softener

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

Stool Softener Laxative

Gentle & Effective, 

Stimulant-free,

Relieves Constipation

SOFTGELS

**This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® Regular Strength Stool Softener.

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

DIST. BY MEIJER DISTRIBUTION, INC,

GRAND RAPIDS, MI 49544

Do Not Use (Do not use)

if you are presently taking mineral oil, unless told so by a doctor.

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

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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 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 (1-800-222-1222) 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
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)