Label: WOMANS LAXATIVE- bisacodyl tablet, coated
- NDC Code(s): 55910-253-25
- Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- 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 December 2, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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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
- it may cause stomach discomfort, faintness and cramps
- Directions
- Other information
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Inactive ingredients
acacia, calcium sulfate anhydrous, 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
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Principal Display Panel
Compare to active ingredient of Dulcolax® Pink® Laxative*
Women's Gentle Laxative Tablets
Bisacodyl 5 mg
Stimulant laxative
Gentle enough for sensitive stomachs
Tablets
Comfort Coated
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor or Dulcolax® Pink® Laxative
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
- Product Label
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INGREDIENTS AND APPEARANCE
WOMANS LAXATIVE
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-253 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 ACACIA (UNII: 5C5403N26O) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) GELATIN (UNII: 2G86QN327L) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) 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:55910-253-25 25 in 1 CARTON 06/30/2018 06/30/2025 1 1 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 06/30/2018 06/30/2025 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)