GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE- bisacodyl tablet

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

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

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE
bisacodyl tablet

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)

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

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

gentle laxative for women by