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.

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