Label: SENNA tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-677-07, 67046-677-14, 67046-677-15, 67046-677-20, view more67046-677-21, 67046-677-28, 67046-677-30, 67046-677-60, 67046-677-62 - Packager: Contract Pharmacy Services-PA
- 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 September 25, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SENNA
senna tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-677(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:67046-677-07 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 2 NDC:67046-677-62 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 3 NDC:67046-677-14 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 4 NDC:67046-677-15 15 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 5 NDC:67046-677-60 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 6 NDC:67046-677-20 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 7 NDC:67046-677-21 21 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 8 NDC:67046-677-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 9 NDC:67046-677-28 28 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/25/2017 Labeler - Contract Pharmacy Services-PA (945429777) Establishment Name Address ID/FEI Business Operations Coupler Enterprises Inc. 945429777 relabel(67046-677)