SENOKOT-S - docuset sodium pill 
Ajes Pharmaceuticals,LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool Softner

Laxative

Keep Out of Reach of Children

In case of overdose, get medical help or contact

a Poison Control Center right away.

Uses

Relieves occasional constipation (irregularity)

Generally causes a bowel movement in 6-12 hours

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

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  

Enter section

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

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

copy of label

SENOKOT-S 
docuset sodium pill
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 340 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg  in 340 mg
Inactive Ingredients
Ingredient NameStrength
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
Colororange (orange color) Scoreno score
ShapeROUND (Pill) Size10mm
FlavorImprint Code C18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42787-105-121 in 1 BOX
150000 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/01/2012
Labeler - Ajes Pharmaceuticals,LLC (159945393)
Establishment
NameAddressID/FEIBusiness Operations
Ajes Pharmaceuticals,LLC159945393manufacture(42787-105) , repack(42787-105) , relabel(42787-105)

Revised: 5/2014
Document Id: 6558ce50-cba7-464e-9cad-a0206629c2ef
Set id: abecc082-4c04-4fae-b8e5-91ddc54d6e0c
Version: 1
Effective Time: 20140525
 
Ajes Pharmaceuticals,LLC