Label: ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release
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- NDC Code(s): 0536-3381-01, 0536-3381-10
- Packager: RUGBY 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 July 15, 2020
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- 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
- KEEP OUT OF REACH OF CHILDREN
- KEEP OUT OF REACH OF CHILDREN
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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 ...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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ENTERIC COATED STIMULANT LAXATIVE
bisacodyl tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3381 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 FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SHELLAC (UNII: 46N107B71O) ACACIA (UNII: 5C5403N26O) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color orange Score no score Shape ROUND Size 6mm Flavor Imprint Code TCL;003 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-3381-01 100 in 1 BOX; Type 0: Not a Combination Product 09/22/2012 2 NDC:0536-3381-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/22/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/22/2012 Labeler - RUGBY LABORATORIES INC (079246066) Registrant - TIME CAP LABS, INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(0536-3381)
