LAXATIVE ENTERIC COATED- bisacodyl tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

P & L Development, LLC

INN (International Name):

BISACODYL

Composition:

BISACODYL 5 mg

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

Summary of Product characteristics

LAXATIVE ENTERIC COATED- BISACODYL TABLET, COATED
P & L DEVELOPMENT, 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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BISACODYL ENTERIC COATED TABLET
ACTIVE INGREDIENT (IN EACH TABLET)
Bisacodyl, USP 5 mg
PURPOSE
Stimulant laxative
USE
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
stomach pain, nausea or vomiting
a sudden change in bowel habits that lasts for more than 2 weeks
WHEN USING THIS PRODUCT
do not chew or crush tablet(s)
it may cause stomach discomfort, faintness and cramps
do not use within 1 hour after taking an antacid or milk
STOP USE AND ASK A DOCTOR IF
you have rectal bleeding or no bowel movement after using this
product. 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 of age and overtake 1 to 3 tablets in a
single daily dose
children 6 to under 12 years of age
take 1 tablet in a single dose
children under 6 years of age
ask a doctor
OTHER INFORMATION
store between 20-25ºC (68-77 F)
INACTIVE INGREDIENTS
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax,
colloidal silicon
dioxide, corn starch, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6
Aluminum Lake,
gelatin, iron oxide, iron oxide Black, iron oxide Yellow (iron oxide
ochre), magnesium
stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400,
polyvinyl acetate
phthalate, povidone, shellac, sodium starch glycolate, stearic acid,
sugar, talc, and
titanium dioxide
QUESTIONS OR COMMEN