GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE- bisacodyl tablet
Care One (American Sales Company)

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 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
within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

stomach pain, nausea or vomiting
a sudden change in bowel habits hat lasts more than 2 weeks

When using this product

do not chew or crush tablet(s)
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 (68-77ºF)

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® Laxative†

GENTLE LAXATIVE FOR WOMEN

Bisacodyl 5 mg

FOR GENTLE, DEPENDABLE OVERNIGHT

RELIEF STIMULANT LAXATIVE

TABLETS

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

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

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.

Product Label

CareOne Gentle Laxative For Women

GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-120
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)
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)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-120-30	2 in 1 CARTON	07/15/2010	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	07/15/2010	12/31/2021

Labeler - Care One (American Sales Company) (809183973)

Revised: 10/2020

Document Id: 3ffaa40b-d94f-4eec-9290-dfeb8c6dcfd3

Set id: 1e9f02f7-d672-4f2e-a341-e5975b312d4b

Version: 8

Effective Time: 20201021

Care One (American Sales Company)