SENNOSIDES, DOCUSATE SODIUM- sennosides, docusate sodium tablet, film coated
Contract Pharmacal Corp.

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5609 - Export

Avrio Label

SENNOSIDES, DOCUSATE SODIUM
sennosides, docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-5609
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GUAR GUM (UNII: E89I1637KE)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	SS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-5609-5	1 in 1 CARTON	11/16/2020
1		120 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:10267-5609-7	1 in 1 CARTON	11/17/2020
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:10267-5609-6	1 in 1 CARTON	05/07/2021
3		20 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:10267-5609-1	1 in 1 CARTON	11/04/2021
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:10267-5609-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		11/16/2020

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		057795122	pack(10267-5609) , label(10267-5609)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		078666313	label(10267-5609) , pack(10267-5609)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		079157508	manufacture(10267-5609)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		968334974	manufacture(10267-5609)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		968335112	manufacture(10267-5609)

Revised: 5/2024

Document Id: 17e45a26-bb3d-7027-e063-6294a90afa03

Set id: c3f2a947-6ca4-d099-e053-2a95a90ac76a

Version: 3

Effective Time: 20240507

Contract Pharmacal Corp.