WOMANS LAXATIVE- bisacodyl tablet, coated
Healthy Accents (DZA Brands, LLC)

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 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 to 12 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 may 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 older	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, polythylene glycol (PEG 400), povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

Questions or comments?

Call toll free 1-866-322-2439

Principal Display Panel

woman’s laxative

bisacodyl, 5 mg

stimulant laxative for gentle, dependable overnight relief

compare to Correctol® active ingredient*

coated tablets

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 04074

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

For product questions or concerns contact us at 1-866-322-2439.

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.

Package Label

Healthy Accents Woman's Laxative Tablets

WOMANS LAXATIVE
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-174
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)
FERROUS OXIDE (UNII: G7036X8B5H)
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)
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	10mm
Flavor		Imprint Code	TCL057
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55316-174-65	2 in 1 CARTON	09/13/2010	12/31/2021
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	09/13/2010	12/31/2021

Labeler - Healthy Accents (DZA Brands, LLC) (090322194)

Revised: 10/2020

Document Id: 86347cdf-1e12-4a73-b276-30fa86793ce8

Set id: 5dc02d4c-563b-483a-af15-47d2ef4868f5

Version: 6

Effective Time: 20201028

Healthy Accents (DZA Brands, LLC)