Label: SENNA tablet, coated
- NDC Code(s): 45865-624-30, 45865-624-49, 45865-624-60
- Packager: medsource pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0904-6434
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 19, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- Package Label - Bottle of 100
-
INGREDIENTS AND APPEARANCE
SENNA
senna tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-624(NDC:0904-6434) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 8.6 mg Inactive Ingredients Ingredient Name Strength 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 Color brown Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL080 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45865-624-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018 2 NDC:45865-624-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018 3 NDC:45865-624-49 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/09/2015 Labeler - medsource pharmaceuticals (833685915) Registrant - TIME CAP LABORATORIES, INC (037052099) Establishment Name Address ID/FEI Business Operations medsource pharmaceuticals 833685915 repack(45865-624)
