Label: GENTLE LAXATIVE- bisacodyl tablet, delayed release
- NDC Code(s): 21130-410-20, 21130-410-52
- Packager: BETTER LIVING BRANDS 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 June 1, 2023
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- 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 tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-410 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 CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) ACACIA (UNII: 5C5403N26O) GELATIN (UNII: 2G86QN327L) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color orange Score no score Shape ROUND Size 6mm Flavor Imprint Code TCL003 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-410-52 1 in 1 CARTON 06/01/2023 1 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:21130-410-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 06/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/01/2023 Labeler - BETTER LIVING BRANDS LLC. (009137209) Registrant - Time Cap Labs Inc. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(21130-410)