CVS HEALTH STOOL SOFTENER- docusate sodium capsule

CVS Health Stool Softener by

Drug Labeling and Warnings

CVS Health Stool Softener by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

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

PREGNANCY OR BREAST FEEDING

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

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 3 mg VERY LOW
SODIUM
■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F). Keep tightly closed.

Inactive ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene
glycol-400, povidone, propylene glycol, purified water,
sorbitol solution, titanium dioxide

QUESTIONS

Questions or comments? 1-888-333-9792

WARNINGS

PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the
active ingredient
in Colace

Stool
Softener
DOCUSATE SODIUM, 50 mg
Stimulant free
Gentle & effective
Comfortable relief
of constipation

Actual Bottle Size
on Side Pane

100 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®.

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

INGREDIENTS AND APPEARANCE

CVS HEALTH STOOL SOFTENER 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-523
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	S10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-523-01	1 in 1 CARTON	06/05/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/05/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(69842-523)