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: 65155-408
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)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Propylene glycol ( UNII: 6DC9Q167V3)
Sorbitol ( UNII: 506T60A25R)
Water ( UNII: 059QF0KO0R)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Mannitol ( UNII: 3OWL53L36A)

Product Characteristics

Score 1 Shape OVAL
Imprint Code A92 Size 12 mm
Color red

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 65155-408-01 100 in 1 BOTTLE 2020/03/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part334 USA 2020/03/01

Labeler - Bene Health OTC( 830110347)

Establishment

Name ID/FEI Business Operations
Bene Health OTC 830110347 pack( 65155-408)