WOMENS GENTLE LAXATIVE- bisacodyl tablet, delayed release
Topco Associates, 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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Topcare 44-676A

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 stomach 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 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)
see end flap for expiration date and lot number
avoid excessive humidity

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?

1-888-423-0139

Principal Display Panel

+TopCare®
health

NDC 36800-676-01

Women's Gentle
Laxative

BISACODYL USP 5 mg • STIMULANT LAXATIVE

Gentle, Dependable, Relief
from Constipation

30 ENTERIC COATED
TABLETS

actual size

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

50844 REV011967601

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZZSE

QUALITY GUARANTEED

TopCare 44-676A

WOMENS GENTLE LAXATIVE
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-676
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
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)

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:36800-676-01	2 in 1 CARTON	05/01/2019
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	05/01/2019

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(36800-676)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(36800-676) , pack(36800-676)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(36800-676)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(36800-676)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(36800-676)

Revised: 9/2022

Document Id: c14a3300-5d83-4773-9464-4af192b7d318

Set id: f437550a-67ef-4576-80b9-b9af4cff4139

Version: 6

Effective Time: 20220917

Topco Associates, LLC