SENNA- senna tablet, coated 
Contract Pharmacy Services-PA

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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677 Senna 8.6 mg

LABEL

SENNA 
senna tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-677(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:67046-677-077 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
2NDC:67046-677-6260 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
3NDC:67046-677-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
4NDC:67046-677-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
5NDC:67046-677-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
6NDC:67046-677-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
7NDC:67046-677-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
8NDC:67046-677-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
9NDC:67046-677-2828 in 1 BLISTER PACK; Type 0: Not a Combination Product09/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/25/2017
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIBusiness Operations
Coupler Enterprises Inc.945429777relabel(67046-677)

Revised: 9/2017
Document Id: 5a06633b-1f84-0ad9-e053-2991aa0a21a7
Set id: 5a06633b-1f83-0ad9-e053-2991aa0a21a7
Version: 1
Effective Time: 20170925
 
Contract Pharmacy Services-PA