Label: WOMENS GENTLE LAXATIVE- bisacodyl tablet
- NDC Code(s): 21130-555-30
- 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 August 7, 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 red #27 aluminum lake, FD&C blue #2 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
WOMENS GENTLE LAXATIVE
bisacodyl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-555 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 (UNII: WAT0DDB505) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) CARNAUBA WAX (UNII: R12CBM0EIZ) GELATIN (UNII: 2G86QN327L) ACACIA (UNII: 5C5403N26O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color pink Score no score Shape ROUND Size 6mm Flavor Imprint Code TCL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-555-30 2 in 1 CARTON 07/10/2023 1 15 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 07/10/2023 Labeler - BETTER LIVING BRANDS LLC. (009137209) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(21130-555)