drug facts

drug facts
SPL v4
SPL
SPL Set ID 9019ae9e-da3e-4ed1-b83e-d9a6375e9c30
Route
oral
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
d&c red no. 33 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 ammonia anhydrous citric acid alcohol isopropyl alcohol lecithin, soybean mineral oil butyl alcohol potassium hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: PC18 Shape: oval Color: red Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-30
Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 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 5 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Description

Docusate sodium 100 mg

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN COLACE® REGULAR STRENGTH STOOL SOFTENER†

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

GENTLE & EFFECTIVE

RELIEVES CONSTIPATION

STIMULANT-FREE

SOFTGELS

†Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

Avrio Health L.P., is not affiliated with the Kroger Co. or this product

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

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

Do Not Use

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

Product Label
KROGER HEALTH Stool Softener
Questions Or Comments?

Call 1-800-632-6900

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 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 in 12 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 5 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN COLACE® REGULAR STRENGTH STOOL SOFTENER†

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

GENTLE & EFFECTIVE

RELIEVES CONSTIPATION

STIMULANT-FREE

SOFTGELS

†Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

Avrio Health L.P., is not affiliated with the Kroger Co. or this product

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

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

Do Not Use (Do not use)

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

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

Call 1-800-632-6900

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 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:21.324807 · Updated: 2026-03-14T23:10:42.831626