WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated

WOMENS GENTLE LAXATIVE by

Drug Labeling and Warnings

WOMENS GENTLE LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Preferred Plus (Kinray). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces a bowel movement in 6 to12 hours

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

• take with a glass of water

• 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

• each tablet contains: calcium 15 mg
• store between 20º-25ºC (68º-77ºF)

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredient in Correctol®

Women’s Gentle Laxative

Bisacodyl Stimulant Laxative

For Dependable, Natural Overnight Relief

Tablets

Each Enteric Coated Tablet Contains 5 mg Bisacodyl

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.

*This product is not manufactured or distributed by MSD Consumer Care Inc., distributor ofCorrectol®.

Distributed by: Kinray, LLC.

152-35 Tenth Avenue

Whitestone, NY  11357

Package Label

Preferred Plus Women's Gentle Laxative

 

INGREDIENTS AND APPEARANCE

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-039
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. 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
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: 61715-039-30	2 in 1 CARTON	08/02/2010
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	08/02/2010

Labeler - Preferred Plus (Kinray) (012574513)