DG™ Health Stool Softener Clear

Set ID
2b29df80-b142-474b-8139-fbfd456ae09d
Manufacturer
Dolgencorp, Inc.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:47:21

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softner

Uses

Uses

relieves occasional constipation (irregularity) this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Warnings

Do not use

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

Ask a doctor before use if you have

stomach pain nausea vomittiong a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition. yo need to use a stool softener laxative for more than 1 week

Directions And Dosage

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 of age: ask a doctor

Other Label Information

Inactive ingredients

gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-309-9030

PRINCIPAL DISPLAY PANEL

DGTM Health Compare to the active ingredient of Colace®* STOOL SOFTENER CLEAR DOCUSATE SODIUM 100 mg Relieves constipation Gentle Relief Stimulant-Free Dye-Free 100 Softgels * This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.

Products

NDC Codes

Ingredients

NameUNIIKind
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softner

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity) this product generally produces a bowel movement within 12 to 72 hours

WARNINGS SECTION

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach pain nausea vomittiong a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition. yo need to use a stool softener laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ,ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

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 of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

Store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DGTM Health Compare to the active ingredient of Colace®* STOOL SOFTENER CLEAR DOCUSATE SODIUM 100 mg Relieves constipation Gentle Relief Stimulant-Free Dye-Free 100 Softgels * This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc29a1deef-0e06-bebd-e063-6294a90ad432.xml2024-12-22
otc0bf24454-c104-5ce6-e063-6294a90a4b80.xml2023-12-15
otcedc5f623-9c95-0e7f-e053-2a95a90aec94.xml2022-11-19
otcd20478ec-0e7b-716f-e053-2995a90ab77b.xml2021-12-01
otcb5e42e57-2ae8-327e-e053-2a95a90aea24.xml2020-12-08
otc8968a692-099d-ced1-e053-2a95a90aee0f.xml2019-05-22
otcStool Softener.jpg2019-05-22