LAXATIVE ENTERIC COATED- bisacodyl 5mg tablet, sugar coated

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

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Active ingredient:
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)
Available from:
Marc Glassman, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant Laxative - for temporary 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:
68998-404-92

LAXATIVE ENTERIC COATED- bisacodyl 5mg tablet, sugar coated

Marc Glassman, 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.

----------

Assured 44-327

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpos e

Stimulant Laxative

Us es

for temporary 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

abdominal pain, nausea or vomiting

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

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,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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 of age and over: 1 to 3 tablets in a single dose, once daily

Children 6 to under 12 years of age: take 1 tablet once daily

Children under 6 years of age: consult a doctor

Other information

store between 68º to 77ºF (20º to 25ºC)

do not use if blister unit is broken or torn

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

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

triethyl citrate

Principal display panel

Laxative

LAXATIVE ENTERIC COATED

bisacodyl 5mg tablet, sugar coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 9 9 8 -40 4

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)

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

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 (UNII: FZ9 8 9 GH9 4E)

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

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

Contains

Marc Glassman, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 8 9 9 8 -40 4-

1 in 1 CARTON

0 3/25/20 0 2

1

25 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

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 3/25/20 0 2

Labeler -

Marc Glassman, Inc. (094487477)

Revised: 9/2019

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