Stool softener capsule, liquid filled

Ingredients and appearance - Product information

Stool softener capsule, liquid filled- Docusate sodium

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 15127-655
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Docusate sodium ( UNII: F05Q2T2JA0)( Docusate - UNII: M7P27195AG ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin, unspecified ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Mineral oil ( UNII: T5L8T28FGP)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)
Citric acid monohydrate ( UNII: 2968PHW8QP)

Product Characteristics

Color ORANGE (clear) Imprint Code 655
Score 1 Shape OVAL
Size 13 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part334 USA

Labeler - L&R Distributors, Inc.( 012578514)

Establishment

Name ID/FEI Business Operations
L&R Distributors, Inc. 012578514 API MANUFACTURE( 15127-655)