drug facts

drug facts
SPL v2
SPL
SPL Set ID ccec364a-3135-4a5d-b4b0-86b832387b4e
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
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 anhydrous citric acid alcohol ammonia lecithin, soybean mineral oil butyl alcohol potassium hydroxide isopropyl alcohol

Identifiers & Packaging

Pill Appearance
Imprint: PC18 Shape: oval Color: red Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-03-04
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 of Colace® Regular Strength Stol Softener**

Stool Softener

Docusate Sodium 100 mg

Stool softener laxative

  • Gentle
  • Dependable
  • Stimulant-free

SOFTGELS

**This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

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 told to do so by a doctor.

Product Label
DOLLAR GENERAL HEALTH Stool Softener Laxative
Questions Or Comments?

Call 1-888-309-9030

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
  • 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 of Colace® Regular Strength Stol Softener**

Stool Softener

Docusate Sodium 100 mg

Stool softener laxative

  • Gentle
  • Dependable
  • Stimulant-free

SOFTGELS

**This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

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 told to do so by a doctor.

Product Label
DOLLAR GENERAL HEALTH Stool Softener Laxative
Questions Or Comments? (Questions or comments?)

Call 1-888-309-9030

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
  • 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: 2026-02-15T12:02:52.812490 · Updated: 2026-03-14T23:02:40.652524