Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

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 a doctor before use if you have

stomach pain
nausea
vomiting
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 could be signs of a serious condition.
you need to use a laxative for more than 1 week

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 (1-800-222-1222) right away.

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 1-3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

each softgel contains:sodium 5 mg
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient of Colace® Regular Strength Stol Softener**

Stool Softener

Docusate Sodium 100 mg

Stool softener laxative

Gentle
Dependable
Stimulant-free

SOFTGELS

**This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE,

GOODLETTSVILLE, TN 37072

Product Label

TopCare Stool Softener Softgels

STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-638
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Product Characteristics
Color	red, white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	PC18
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-638-25	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	12/30/2021

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Drug Facts