Colace
Colace
Approved
Approval ID
9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Atlantis Consumer Healthcare, Inc.
DUNS: 118983925
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docusate sodium - sennosides
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67618-110
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Docusate sodium - sennosides
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (20)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 50 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/19/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/2/2020
OTC - PREGNANCY OR BREAST FEEDING SECTION
LOINC: 53414-9Updated: 12/18/2023
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/19/2023
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 12/18/2023
WARNINGS SECTION
LOINC: 34071-1Updated: 9/2/2020
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 12/18/2023
OTC - ASK DOCTOR SECTION
LOINC: 50569-3Updated: 12/19/2023
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 12/18/2023
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 12/19/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/19/2023
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 12/19/2023
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 12/22/2023