BISACODYL tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)

Available from:

Chain Drug Consortium

INN (International Name):

BISACODYL

Composition:

BISACODYL 5 mg

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

Summary of Product characteristics

BISACODYL- BISACODYL TABLET, DELAYED RELEASE
CHAIN DRUG CONSORTIUM
_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._
----------
PREMIER VALUE 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
a sudden change in bowel habits that lasts more than 2 weeks
stomach pain, nausea or vomiting
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 need to use a laxative for more than 1 week
you have rectal bleeding or fail to have a bowel movement after use of
a laxative.
These could be signs of a serious condition.
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 yearsask a doctor
_OTHER INFORMATION_
store at 25°C (77°F); excursions permitted between 15°-30°C
(59°-86°F)
avoid excessive humidity
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, propylp