WOMENS LAXATIVE- bisacodyl tablet, delayed release
Marc Glassman, 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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232 - Womens Laxative

Active ingredient

Bisacodyl USP 5mg

Purpose

Stimulant Laxative

Uses

■ for relief of occasional constipation and irregularity

■ this product usually causes bowel movements in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing.

Ask a doctor before use if you have

■ abdominal pain, nausea or vomiting

■ a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

■ do not chew or crush

■ do not take this product within 1 hour of taking antacid or milk

■ you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

■ rectal bleeding or failure to have a bowel movement after use of a laxative

These could be signs of a serious condition.

■ you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

■ take with water

■ Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily

■ Children 6 to 12 years of age: take 1 tablet once daily

■ Children under 6 years of age: consult a doctor

Other information

■ store between 68º to 77ºF (20º to 25ºC)

■ do not use if blister unit is broken or torn

■ Calcium content: 16.33mg per tablet

Inactive ingredients

acacia, calcium sulfate anhydrous, carnauba wax, 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 400, povidone, shellac, silicon dioxide, sodium starch glycolate, stearate acid, sugar, talc, titanium dioxide, triacetin

Principal Display Panel

Womens Laxative

WOMENS LAXATIVE
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68998-232
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	TCL;057
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68998-232-85	2 in 1 CARTON	07/01/2014	12/30/2020
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/01/2014	12/30/2020

Labeler - Marc Glassman, Inc. (094487477)

Revised: 12/2016

Document Id: 38b27a93-20ef-49a1-b70a-4272f7a94813

Set id: ec137bc1-0db2-43ab-9c79-51d9df67888e

Version: 4

Effective Time: 20161223

Marc Glassman, Inc.