CVS Health Stool Softener Clear

Set ID
4526eefd-b345-4bdb-9cfa-5cacbb763e16
Manufacturer
CVS Pharmacy
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:44:11

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each softgel)

Docusate sodium 50 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 6 softgels daily children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor

Other Label Information

Other information

■ each softgel contains: sodium 0.02 mg ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Compare to the active ingredient in Colace® Clear* Stool Softener DOCUSATE SODIUM, 50 mg • Stimulant free • Gentle & effective DYE FREE Actual Bottle Size on Side Pane 30 SOFTGELS RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace® Clear. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2019 CVS/pharmacy CVS.com® 1-800-SHOP CVS Made in India V-33609

Products

NDC Codes

Ingredients

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

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 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 AND PRECAUTIONS 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 6 softgels daily children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each softgel contains: sodium 0.02 mg ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Compare to the active ingredient in Colace® Clear* Stool Softener DOCUSATE SODIUM, 50 mg • Stimulant free • Gentle & effective DYE FREE Actual Bottle Size on Side Pane 30 SOFTGELS RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace® Clear. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2019 CVS/pharmacy CVS.com® 1-800-SHOP CVS Made in India V-33609

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
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otc0bdd78c5-378b-082a-e063-6294a90aedea.xml2023-12-07
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otcb5e29b2b-6c4d-7585-e053-2995a90af1a1.xml2020-12-08
otc8a97b1db-d669-9a47-e053-2995a90a5676.xml2019-06-07
otcCVS Docusate Clear 30CT.jpg2019-06-07