Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 8b033d56-b95b-4905-9f33-cf2fbd61ce35
Route
ORAL
Published
Effective Date 2024-03-15
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 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-30

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 to 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 directed by a doctor.

Product Label
DOLLAR GENERAL Docusate Sodium 100 mg softgels
Other Information
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77º); excursions permitted between 15-30ºC (59º-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 1-888-309-9030

Principal Display Panel

Compare to active ingredient in Dulcolax® Stool Softener**

Gentle Relief

Stool Softener

Docusate Sodium, 100 mg

Stool softener laxative

Fast, Dependable Relief of Occasional Constipation

100 mg

Softgels

**This product is not manufactured 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

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN  37072

Stop Use and Ask A Doctor If
  • you have rectal bleeding or no bowel movement after using a laxative. These could be sign 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 USP,  100 mg

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

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 to 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 directed by a doctor.

Product Label
DOLLAR GENERAL Docusate Sodium 100 mg softgels
Other Information (Other information)
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77º); excursions permitted between 15-30ºC (59º-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 1-888-309-9030

Principal Display Panel

Compare to active ingredient in Dulcolax® Stool Softener**

Gentle Relief

Stool Softener

Docusate Sodium, 100 mg

Stool softener laxative

Fast, Dependable Relief of Occasional Constipation

100 mg

Softgels

**This product is not manufactured 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

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN  37072

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or no bowel movement after using a laxative. These could be sign 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 USP,  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 more than 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)