GENTLE LAXATIVE- bisacodyl tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)
Available from:
Topco Associates, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant laxative - for relief of occasional constipation and irregularity - this product generally produces bowel movement in 6 to 12 hours
Authorization status:
OTC monograph not final
Authorization number:
36800-327-03

GENTLE LAXATIVE- bisacodyl tablet, coated

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.

----------

Topcare 44-327

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

for relief of occasional constipation and 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

stomach pain, nausea or vomiting

a sudden change in bowel habits that lasts more than 2 weeks

When using this product

do not use within 1 hour after taking an antacid or milk

do not chew or crush tablet(s)

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 (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

avoid excessive humidity

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

see end flap for expiration date and lot number

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch,

D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black,

lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl

acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium

alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin,

triethyl citrate

Questions or comments?

1-888-423-0139

Principal display panel

+TopCare

Health™

hDC 36800-327-03

COMPARE TO

DULCOLAX® LAXATIVE

TABLETS ACTIVE

INGREDIENT*

Gentle

Laxative

BISACODYL USP 5 mg STIMULANT LAXATIVE

Gentle, Dependable Overnight

Relief from Constipation

10 COMFORT COATED TABLETS

actual

size

our pharmacist recommended

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by

Sanofi-Aventis Deutschland GMBH, owner of the registered

trademark Dulcolax® Laxative Tablets.

50844 ORG011932703

ELK GROVE VILLAGE, IL 60007

© TOPCO LNKA0319

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/48ztk3

QUALITY GUARANTEED

Topcare 4 4 -327

GENTLE LAXATIVE

bisacodyl tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -327

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISACO DYL (UNII: 10 X0 70 9 Y6 I) (DEACETYLBISACODYL - UNII:R0 9 0 78 E41Y)

BISACODYL

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACACIA (UNII: 5C540 3N26 O)

AMMO NIA (UNII: 5138 Q19 F1X)

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 ALUMINUM LAKE (UNII: CQ3XH3DET6 )

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

Po lyvinyl Aceta te Phtha la te (UNII: 58 QVG8 5GW3)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SHELLAC (UNII: 46 N10 7B71O)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM ALGINATE (UNII: C26 9 C4G2ZQ)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:36 8 0 0 -327-

1 in 1 CARTON

0 5/15/20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part334

0 5/15/20 19

Labeler -

T opco Associates, LLC (006935977)

Topco Associates, LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(36 8 0 0 -327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(36 8 0 0 -327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(36 8 0 0 -327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(36 8 0 0 -327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(36 8 0 0 -327)

Revised: 4/2020

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