WOMENS LAXATIVE- bisacodyl tablet, coated 
Dolgencorp, Inc.

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.

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Gentle Laxative

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

Warnings

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 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

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week 

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age take 1 tablet in a single daily dose
 children under 6 years of age ask a doctor

Other information

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

Questions or comments?

 Call 1-888-309-9030

PRINCIPLA DISPLAY PANEL

Compare to active ingredient of Dulcolax® Pink® Laxative*

Women's Gentle Laxative Tablets

Bisacodyl 5 mg

Stimulant laxative

Gentle, Overnight relief

*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.

image description

WOMENS LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-848
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
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 400 (UNII: B697894SGQ)  
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
ColorpinkScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-848-2525 in 1 CARTON03/12/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/12/2020
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2021
Document Id: d218a279-8c8b-4b1f-e053-2a95a90af557
Set id: bf173818-8f8c-43a0-9c89-095aec13d046
Version: 2
Effective Time: 20211201
 
Dolgencorp, Inc.