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Bisacodyl

Sunrise Pharmaceutical Inc

Bisacodyl USP 5 mg Laxative




FULL PRESCRIBING INFORMATION

Bisacodyl USP 5mg.

Stimulant laxative.

For temporary relief of occasional constipation and irregularity

This product generally produces bowel movement in 6 to 12 hours.

Do not use if you cannot swallow without chewing.

Stomach pain, nausea or vomiting

A sudden change in bowel habits that lasts for more than 2 weeks.

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.

You have rectal bleeding or no bowel movement after using this product. These could be signs of serious condition.

You need to use laxative for more than 1 week

Ask a health professional before use.

Dosage and Administration text

In case of overdose, get medical help or contact a Poison Control Center right away.

Take with a glass of water

Adults and children 12 years and over 1 to 3 tablets in a single daily dose
Children 6 to under 12 years 1 tablet in a single daily dose
Children under 6 years Ask a doctor

Store at 20°-25°C(68°-77°F)

Calcium sulfate, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, edible ink, FD & C yellow #6, gelatin, hydroxypropylymethyl cellulose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline celloluse, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate.

Bisacodyl

Bisacodyl

Bisacodyl TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11534-013
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bisacodyl Bisacodyl 5 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM SULFATE
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
Hypromellose 2910 (5 Mpa.s)
KAOLIN
LACTOSE
MAGNESIUM STEARATE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
Mineral Oil
polyethylene glycol
propylene glycol
STEARIC ACID
SUCROSE
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 6 mm S1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11534-013-25 25 in 1 BOTTLE
2 NDC:11534-013-01 100 in 1 BOTTLE
3 NDC:11534-013-03 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2005-07-08


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Be sure to consult your doctor before taking any medication!
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