SENNA- senna tablet, coated 
MAJOR 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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191R MAJOR SENNA LAXATIVE TABS

LABEL

SENNA 
senna tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6434-801000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/202001/15/2023
2NDC:0904-6434-59100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/202001/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/09/201501/15/2023
Labeler - MAJOR PHARMACEUTICALS (191427277)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(0904-6434)

Revised: 1/2023
Document Id: f27177b9-dd30-a93e-e053-2a95a90a593a
Set id: 8dae128b-9c04-4f05-95dc-fb7d83a16398
Version: 6
Effective Time: 20230117
 
MAJOR PHARMACEUTICALS