Label: GENTLE LAXATIVE- bisacodyl tablet
- NDC Code(s): 67091-385-25
- Packager: WinCo Foods LLC
- 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 January 6, 2022
If you are a consumer or patient please visit this version.
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- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Ask a doctor before use if you have
• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks
When using this product
• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• you may have stomach discomfort, faintness or cramps
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients acacia, 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 phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
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INGREDIENTS AND APPEARANCE
GENTLE LAXATIVE
bisacodyl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-385 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 CARNAUBA WAX (UNII: R12CBM0EIZ) GELATIN (UNII: 2G86QN327L) SUCROSE (UNII: C151H8M554) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM STEARATE (UNII: 70097M6I30) SHELLAC (UNII: 46N107B71O) ACACIA (UNII: 5C5403N26O) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) 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:67091-385-25 1 in 1 CARTON 01/12/2022 1 25 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/12/2022 Labeler - WinCo Foods LLC (056098817) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(67091-385)