Stool Softener
FDA Label NDC 69842-319

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 for the product Stool Softener (NDC 69842-319). 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, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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DRUG FACTS

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

Otc - Active Ingredient

Otc - Purpose

Active ingredients (in each softgel)Purpose
Docusate sodium 50 mg  Stool softener
 Sennosides 8.6 mg Stimulant Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

Warnings

Warnings

Otc - Do Not Use

Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Otc - Ask Doctor

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 - Stop 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 may indicate a serious condition.

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.

Directions

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
    •  adults and children 12 years of age or over take 2-4 softgels daily
     children 6 to under 12 years of age       take 1-2 softgels daily
     children 2 to under 6 years of age    take upto 1 softgel daily
     children under 2 ask a doctor

Other Information

  • each softgel contains: calcium 2 mg and sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive Ingredients

Aerosil, beeswax, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions?

Call 1-888-333-9792 Monday-Friday 9AM-5PM EST

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Compare to the
active ingredients in
COLACE® 2-IN-1*

Liquid Filled Softgels

NDC 69842-319-60

Stool Softener
DOCUSATE SODIUM, 50 mg
SENNOSIDES, 8.6 mg
Plus stimulant laxative

Package Contains One Bottle

60 SOFTGELS

Actual Size

*This product is not manufactured or distributed by Purdue Products L.P., owner of the
registered trademark COLACE® 2-IN-1.

* Please review the disclaimer below.