Cvs Health Stool Softener Clear
FDA Label NDC 69842-633

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Health Stool Softener Clear (NDC 69842-633). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient(in each softgel), purpose, uses, warnings, otc - ask doctor/pharmacist, otc - do not use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient(In Each Softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

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

Warnings

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

Otc - Ask Doctor/Pharmacist

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

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

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

Otc - 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 right
away. 1-800-222-1222

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 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

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®.

* Please review the disclaimer below.