Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 9983095a-6ef4-4ad7-acc5-e34221fb7c63
Route
ORAL
Published
Effective Date 2024-03-07
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 2021-07-30
Description

Docusate sodium 100 mg

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours
Directions
  • take softgels with a full glass (8 oz) of water
adults and children 12 years and older take 1-3 softgels daily or as directed by a doctor. 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 or as directed by a doctor
children under 2 years  ask a doctor 


Product Label
CVS HEALTH Stool Softener Laxative
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

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in Phillips'® Stool Softener*

Stool Softener

DOCUSATE SODIUM 100 mg

Relieves occasional constipation

  • Stool softener laxative
  • Reliable relief

SOFTGELS

**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'® Stool Softener.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive Woonsocket, RI 02895

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 14 days

Structured Label Content

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

Stool softener laxative

Directions
  • take softgels with a full glass (8 oz) of water
adults and children 12 years and older take 1-3 softgels daily or as directed by a doctor. 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 or as directed by a doctor
children under 2 years  ask a doctor 


Product Label
CVS HEALTH Stool Softener Laxative
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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Phillips'® Stool Softener*

Stool Softener

DOCUSATE SODIUM 100 mg

Relieves occasional constipation

  • Stool softener laxative
  • Reliable relief

SOFTGELS

**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'® Stool Softener.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive Woonsocket, RI 02895

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 14 days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.902018 · Updated: 2026-03-14T23:02:37.591705