Label: BISACODYL tablet, coated
- NDC Code(s): 41226-003-52
- Packager: KROGER COMPANY
- 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 June 1, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
Warnings- Warning: Do not use if you cannot swallow without chewing.
- Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.
- When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BISACODYL
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SUCROSE (UNII: C151H8M554) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, CORN (UNII: O8232NY3SJ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) ACACIA (UNII: 5C5403N26O) TALC (UNII: 7SEV7J4R1U) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARNAUBA WAX (UNII: R12CBM0EIZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 5mm Flavor Imprint Code TCL003 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-003-52 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/01/2020 Labeler - KROGER COMPANY (006999528) Registrant - TIME CAP LABORATORIES INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABS 037052099 manufacture(41226-003)
