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 44-676

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

for relief of occasional constipation (irregularity)
this product generally produces 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

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

When using this product

do not chew or crush tablet(s)
do not use within 1 hour after taking an antacid or milk
you may have discomfort, faintness and cramps

Stop use and ask a doctor if

you have rectal bleeding or fail 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

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 (1-800-222-1222) right away.

Directions

take with a glass of water

adults and children 12 years and over	take 1 to 3 tablets in a single daily dose
children 6 to under 12 years	take 1 tablet in a single daily dose
children under 6 years	ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive humidity
see end flap for expiration date and lot number

Inactive ingredients

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE ™

NDC 64092-121-30

Women's Laxative
Bisacodyl USP, 5 mg
Stimulant Laxative

A gentle action feminine laxative

Gentle, Dependable
Constipation Relief

EACH ENTERIC COATED
TABLET CONTAINS
5 mg BISACODYL

30 TABLETS

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

50844 REV0119A67601

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

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

Healthcare 44-676A

WOMENS LAXATIVE
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64092-121
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
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	B
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64092-121-30	2 in 1 CARTON	09/16/2015
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	09/16/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(64092-121)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(64092-121)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(64092-121)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(64092-121)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(64092-121)

Revised: 3/2021

Document Id: 7cc8a94c-7368-4e26-999a-b0f92826600c

Set id: 84cc2a8c-92d0-4165-962d-563abed6d752

Version: 10

Effective Time: 20210330

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.