WOMENS LAXATIVE- bisacodyl tablet, coated
GREAT LAKES WHOLESALE, MARKETING, & SALES, 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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Healthcare 44-326 Delisted

Active ingredient (in each enteric coated tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

for gentle, overnight relief of occasional constipation (irregularity)
this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

in children under 6 years of age
in persons who cannot swallow without chewing

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
sudden change in bowel movements that persists over a period of 2 weeks

When using this product

do not use for a period longer than 1 week unless directed by a doctor
you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if

rectal bleeding occurs
you fail to have a bowel movement

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

do not chew or crush tablets
do not take within 1 hour after taking an antacid or milk

adults and children over 12 years of age	oral dosage is 1 to 3 tablets in a single or divided daily dose
children 6 to under 12 years of age	oral dosage is 1 tablet in a single daily dose
children under 6 years of age	ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
protect from excessive moisture
see end flap for expiration date and lot number

Inactive ingredients

acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate pthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE™

NDC 64092-120-30

Bisacodyl Stimulant Laxative
Women's Laxative
A gentle action feminine laxative

EACH ENTERIC COATED
TABLET CONTAINS
5 mg BISACODYL

Gentle, Dependable Overnight Relief

*Compare to the active ingredient in Correctol® Tablets

30 TABLETS

*This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark Correctol®.
50844 REV0412G32601

HEALTHCARE GUARANTEE
If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.,
Grand Rapids, MI 49512
www.glwholesale.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Healthcare 44-326

WOMENS LAXATIVE
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64092-120
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;326
Contains

#	Item Code	Package Description
Packaging
1	NDC:64092-120-30	2 in 1 CARTON
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	09/01/2000	12/14/2018

Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(64092-120)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(64092-120)

Revised: 1/2016

Document Id: 1901ef63-d19c-4793-9ce7-c1ef90fa4a68

Set id: 0183b322-af38-4dce-a78e-cc20c4881fcb

Version: 10

Effective Time: 20160114

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.