OTC Medication Information: STOOL SOFTENER

STOOL SOFTENER- docusate sodium and sennosides capsule, gelatin coated
CVS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

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

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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.

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

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

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

PRINCIPAL DISPLAY PANEL

♥CVSHealth™

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.

image description
(click image for full-size original)
STOOL SOFTENER
docusate sodium and sennosides capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-319
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
YELLOW WAX
FD&C RED NO. 40
GELATIN
GLYCERIN
LIGHT MINERAL OIL
POVIDONE K30
WATER
CARBOXYMETHYLCELLULOSE SODIUM
SORBITOL
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color red (OPAQUE) Score no score
Shape CAPSULE (SOFTGEL) Size 12mm
Flavor Imprint Code 584
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-319-60 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (69842-319-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/15/2018
Labeler — CVS (062312574)

Revised: 11/2022 CVS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.