SENNA- senna tablet, coated 
medsource pharmaceuticals

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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Package Label - Bottle of 100

pdp

SENNA 
senna tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-624(NDC:0904-6434)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-624-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
2NDC:45865-624-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
3NDC:45865-624-49100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/09/2015
Labeler - medsource pharmaceuticals (833685915)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
medsource pharmaceuticals833685915repack(45865-624)

Revised: 12/2018
Document Id: 7d623352-7831-8765-e053-2991aa0aae94
Set id: 7d62291a-619b-458a-e053-2a91aa0a1af7
Version: 1
Effective Time: 20181219
 
medsource pharmaceuticals