STOOL SOFTENER REGULAR STRENGTH- docusate sodium capsule, liquid filled

Stool Softener Regular Strength by

Drug Labeling and Warnings

Stool Softener Regular Strength by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12–72 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

fever mucus in the stool

Ask a doctor or pharmacist before use if you are 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 could be signs of a serious condition you need to use a stool softener 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 right away. (1-800-222-1222)

Directions

take only by mouth. Doses may be taken as asingle daily dose or in divided doses.

• adults & children 12 years of age & over: take 1–3 softgels daily
• children 2 to under 12 years of age: take 1 softgel daily
• children under 2 years of age: ask a doctor

Other information

store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) Keep tightly closed

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution

Questions or comments?

1-888-333-9792

Distributed by:

Cabinet Health P.B.C.

Pouch

INGREDIENTS AND APPEARANCE

STOOL SOFTENER REGULAR STRENGTH 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-4176
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-4176-3	30 in 1 POUCH; Type 0: Not a Combination Product	11/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	11/22/2021

Labeler - Spirit Pharmaceuticals LLC (179621011)