WOMENS LAXATIVE by Western Family Foods, Inc. / P & L Development, LLC Drug Facts

WOMENS LAXATIVE by

Drug Labeling and Warnings

WOMENS LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc., P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WOMENS LAXATIVE- bisacodyl tablet, coated 
Western Family Foods, 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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Drug Facts

Active ingredient (in each enteric coated tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

  • for relief of occasional constipation and irregularity. This product generally produces a bowel movement within 8 to 12 hours if taken at bedtime or within 6 hours if taken before breakfast.

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor. Prolonged or continued use of this product can lead to laxative dependency and loss of normal bowel function. Serious side effects from prolonged use or overdose can occur.

Caution

  • do not chew or crush
  • do not give to children under 6 years of age or to persons who cannot swallow without chewing
  • do not take this product within 1 hour after taking an antacid and/or milk
  • this product may cause abdominal discomfort, faintness, rectal burning, and mild cramps

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breast-feeding,

ask a health care 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

  • do not take more than 3 tablets daily
 adults and children 12 years of age and older take 1-3 tablets in a single dose once daily
 children 6 to under 12 years of age take 1 tablet daily
 children under 6 years of age consult a doctor

Other information

  • each tablet contains: calcium 15 mg
  • store at 15º-30ºC (59º-86ºF)
  • keep in a dry place

Inactive ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #7 Calcium Lake, hypromellose phthalate, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Overnight Relief

Dependable, Gentle & Effective

Women's Laxative

BISACODYL USP 5 mg Stimulant Laxative

Comfort Coated TABLETS

*Compare to the Active Ingredient in Correctol®

ENTERIC COATED

*This product is not manufactured or distributed by Schering-Plough, owner of the registered trademark Correctol®.

TAMPER EVIDENT - USE ONLY IF BLISTERS ARE INTACT.

Proudly Distributed by:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208

Product Label

Bisacodyl 5 mg

Western Family Women's Laxative Tablet

 

WOMENS LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55312-120
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. 7 (UNII: ECW0LZ41X8)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
KAOLIN (UNII: 24H4NWX5CO)  
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)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorPINK (polished) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL057
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55312-120-302 in 1 CARTON07/05/201012/31/2019
115 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 FINALpart33407/05/201012/31/2019
Labeler - Western Family Foods, Inc. (192166072)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
 
Western Family Foods, Inc.