SIMPEX BISACODYL LAXATIVE- bisacodyl tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Simpex Pharma Pvt. Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- relives 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

SIMPEX BISACODYL LAXATIVE- BISACODYL TABLET, COATED
SIMPEX PHARMA PVT. LTD
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SIMPEX BISACODYL LAXATIVE
DRUG FACTS
_ACTIVE INGREDIENT (IN EACH TABLET)_
Bisacodyl 5 mg
_PURPOSE_
Stimulant Laxative
USES
relives occasional constipation and irregularity
this product generally produces bowel movement in 6 to 12 hours
WARNINGS
DO NOT USE
if you can not 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 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 or cramps
STOP USE AND ASK A DOCTOR IF
you have rectal bleeding or fail to have a bowel movement after use 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 or overdose, get medical help orcontact 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
ask a doctor
_OTHER INFORMATION_
preserve in well-closed containers at a temperature not exceeding
30°C
avoid excessive humidity
_INACTIVE INGREDIENTS_
anhydrous lactose, colloidal anhydrous silica, hypermellose, iron
oxide red, iron oxide
yellow, macrogol, magnesium stearate, methacrylic acid copolymer type
C,
microcrystalline cellulose, polyethylene glycol 400, polyethylene
glycol 6000, povidone,
sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type
A, talc, titanium
dioxide,triethyle citrate
PACKAGE LABELING:
SIMPEX BISACODYL LAXATIVE
bisacodyl tablet, coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:76457-003
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STREN