Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a1ea0993-2d23-44e3-bc72-e4bf497ab723
Route
ORAL
Published
Effective Date 2024-03-05
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 Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Glycerin Citric Acid Monohydrate Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-30
Description

Docusate Sodium USP, 100 mg

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium USP, 100 mg

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Directions
  • take with a glass of water

adults and children 12 years and over take 1-3 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
Do Not Use

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

Product Label
CARE ONE Stool Softener Laxative
Other Information
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)



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



Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener†

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

FAST, DEPENDABLE RELIEF

OF OCCASIONAL CONSTIPATION

SOFTGELS

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® 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: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147





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



Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be a sign of a serious condition.

  • you need to use a stool softener 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 (1-800-2222-1222) right away.

Active Ingredient (in Each Softgel)

Docusate Sodium USP, 100 mg

Structured Label Content

Uses
  • for 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 1-3 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
Do Not Use (Do not use)

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

Product Label
CARE ONE Stool Softener Laxative
Other Information (Other information)
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)



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



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 Dulcolax® Stool Softener†

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

FAST, DEPENDABLE RELIEF

OF OCCASIONAL CONSTIPATION

SOFTGELS

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® 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: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147





Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks



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 using a laxative. These could be a sign of a serious condition.

  • you need to use a stool softener 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 (1-800-2222-1222) right away.

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

Docusate Sodium USP, 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.961392 · Updated: 2026-03-14T23:02:36.495120