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Drug Facts
Cvs Health Stool Softener Clear
FDA Label NDC 69842-522
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 69842-522). 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
Active Ingredient(In Each Softgel)
Docusate sodium 50 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 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
■
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
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
* Please review the disclaimer below.
