WOMANS LAXATIVE- bisacodyl tablet, coated

womans laxative by

Drug Labeling and Warnings

womans laxative by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC., P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each enteric coated tablet)

 Bisacodyl 5mg

Purpose

 Stimulant laxative

Use

• for relief of occasional constipation and irregularity. This product generally produces 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 of a laxative

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

• 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/tablet
• store at 15º-30ºC (59º-86ºF)
• keep in a dry place
• *This product is not manufactured or distributed by Schering-Plough, owner of the registered trademark Correctol®.

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, and triacetin

Principal Display Panel

 Woman's Laxative Tablets

Stimulant Laxative for gentle, dependable overnight relief

Bisacodyl, 5 mg Tablets

*Compare to Correctol® Active ingredient

Call toll free 1-877-753-3935

TAMPER EVIDENT

USE ONLY IF BLISTERS ARE INTACT.

PRODUCT LABEL

WOMANS LAXATIVE TABLETS

 

INGREDIENTS AND APPEARANCE

WOMANS LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)	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. 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 400 (UNII: B697894SGQ)
POVIDONES (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
Color	PINK	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL057
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-120-30	2 in 1 CARTON
1		15 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	07/09/2010

Labeler - Shopko Stores Operating Co., LLC. (023252638)

Registrant - P and L Development of New York Corporation (800014821)