CVS Health Stool Softener Clear

Set ID
4d77facc-a01b-4b6d-8770-b0a429ec5bfd
Manufacturer
CVS Pharmacy
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:38

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

Uses

■ relieves occasional constipation (irregularity) ■ generally produces bowel movement in 12 to 72 hours

Warnings

Warnings

Do not use ■ if you are presently taking mineral oil, unless told to do so by a doctor

OTC - DO NOT USE SECTION

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 stool softener laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Other Label Information

Other information

■ each softgel contains: sodium 5 mg ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). ■ Keep tightly closed

Inactive ingredients

gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene glycol, purified water, sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

CVS Health Compare to the active ingredient in Colace®* Stool Softener DOCUSATE SODIUM, 100 mg •Relieves constipation Stimulant free Gentle & effective DYE FREE 60 SOFTGELS *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Products

NDC Codes

Ingredients

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

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 softener

Uses

INDICATIONS & USAGE SECTION

■ relieves occasional constipation (irregularity) ■ generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use ■ if you are presently taking mineral oil, unless told to do so by a doctor

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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 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 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each softgel contains: sodium 5 mg ■ 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 (PVP K-30), propylene glycol, purified water, sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Compare to the active ingredient in Colace®* Stool Softener DOCUSATE SODIUM, 100 mg •Relieves constipation Stimulant free Gentle & effective DYE FREE 60 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

XML object
dailymed/4d77facc-a01b-4b6d-8770-b0a429ec5bfd/297e4324-cd2d-6676-e063-6294a90a31fa.xml
XML SHA-256
eafa5efbfe1b8bebd16f2d91020e49180f07788db25388fe6840e3deb92973b4
XML bytes
23453

Legacy File Index

FolderFileDate
otc297e4324-cd2d-6676-e063-6294a90a31fa.xml2024-12-20
otc0bdf3bc9-3715-9494-e063-6394a90a573f.xml2023-12-07
otcedc59015-5f99-7ae3-e053-2a95a90ab3ee.xml2022-11-19
otcd21a6501-4e5b-a842-e053-2995a90aa95f.xml2021-12-02
otc9e546eb9-db30-f473-e053-2995a90a855f.xml2020-02-12
otcColace Clear.jpg2020-02-12