SENOKOT-S- docuset sodium pill

SENOKOT-S by

Drug Labeling and Warnings

SENOKOT-S by is a Otc medication manufactured, distributed, or labeled by Ajes Pharmaceuticals,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purpose

Stool Softner

Laxative

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

In case of overdose, get medical help or contact

a Poison Control Center right away.

INDICATIONS & USAGE

Uses

Relieves occasional constipation (irregularity)

Generally causes a bowel movement in 6-12 hours

WARNINGS

Warnings

Do Not Use

If you are now taking mineral oil,

unless directed by a doctor

Laxative products for longer than 1 week,

unless directed by a doctor

DOSAGE & ADMINISTRATION

Directions - take preferably at bedtime or as directed by a doctor

Age                                                                     Starting dose                                    Maximum Dose

Adults and children 12 years of age or older     2 tablets once a day -                               4 tablets twice a day

children 6 to 12 years of age -                         1 tablet once a day                                    2 tablets twice a day

children 2 to 6 years of age                              1/2 tablet once a day                              1 tablet twice a day

children under 2 years of age                           ask a doctor  

INACTIVE INGREDIENT

Enter section

ASK DOCTOR

Ask a doctor before use if your have rectal bleeding or fail to have

a bowel movement after use of a laxative. These may be signs of   

a serious condition

PREGNANCY

If pregnant or breast-feeding ask a health professional before use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENOKOT-S 
docuset sodium pill

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42787-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg  in 340 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg  in 340 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	orange (orange color)	Score	no score
Shape	ROUND (Pill)	Size	10mm
Flavor		Imprint Code	C18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42787-105-12	1 in 1 BOX
1		50000 mg in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/01/2012

Labeler - Ajes Pharmaceuticals,LLC (159945393)

Establishment
Name	Address	ID/FEI	Business Operations
Ajes Pharmaceuticals,LLC		159945393	manufacture(42787-105) , repack(42787-105) , relabel(42787-105)