BISACODYL 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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

BISACODYL

Composition:

BISACODYL 5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

 Stimulant laxative  -relieves 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 ENTERIC COATED- BISACODYL TABLET, COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, 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(S)
Bisacodyl 5mg
PURPOS E
Stimulant laxative
US E(S )
-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours
WARNINGS
DO NOT USE
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 or 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
PREGNANCY/BREAS TFEEDING
ask a health professions 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 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 of age - take 1 tablet in a single daily
dose
children under 6 years of age - ask a doctor
OTHER INFORMATION
Repackaged by Aphena Pharma Solutions - TN.
See _REPACKAGING INFORMATION_ for available configurations.
STORAGE
-store at 25 degrees C (77 degrees F) excursions permitted between 15
degrees-30 degrees C (59
degrees-86 degrees F)
-use by expiration date on package
-protect from excessive humidity
INACTIVE INGREDIENTS
acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn
starch, D&C Yellow No. 10 lake,
FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearat