GENTLE STOOL SOFTENER- docusate sodium capsule, liquid filled 
RITE AID CORPORATION

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.

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Gentle Stool Softener

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 a single daily dose or in divided doses.

adults & children 12 years of age & overtake 1–3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years of ageask 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, titanium dioxide

Questions or comments?

1-888-333-9792

Principal Display

LabelCartonCarton

GENTLE STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1573
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeOVALSize10mm
FlavorImprint Code 100
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1573-21 in 1 CARTON11/07/2022
125 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/07/2022
Labeler - RITE AID CORPORATION (014578892)

Revised: 12/2022
Document Id: efe155a7-8d41-1c9d-e053-2995a90a09a5
Set id: 1c2c6ebd-f39e-4067-a753-295ea2d3f72d
Version: 3
Effective Time: 20221215
 
RITE AID CORPORATION