Label: SENNOSIDES tablet, sugar coated
- NDC Code(s): 49483-079-00, 49483-079-01
- Packager: TIME CAP LABORATORIES, INC
- 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 November 22, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, Sugar, Talc, Titanium dioxide
- PURPOSE
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DOSAGE & ADMINISTRATION
Directions:
Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day
Children 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
Children under 2 years - Ask a doctor
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENNOSIDES
sennosides tablet, sugar coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-079 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 15 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) ACACIA (UNII: 5C5403N26O) POVIDONE (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) RAW SUGAR (UNII: 8M707QY5GH) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL079 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-079-00 50000 in 1 CARTON; Type 0: Not a Combination Product 08/30/2018 2 NDC:49483-079-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/30/2018 Labeler - TIME CAP LABORATORIES, INC (037052099) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(49483-079)
