Package Label

Package Label
SPL v6
SPL
SPL Set ID 24e5689b-a5d7-479d-b7ec-c9b1d35a6df3
Route
ORAL
Published
Effective Date 2013-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Bisacodyl 5 mg


Medication Information

Warnings and Precautions

Do not use if you cannot swallow without chewing Ask a doctor before use if you have • stomach pain, nausea, vomiting • noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk • it may cause stomach discomfort, faintness and cramps 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.

Indications and Usage

for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

Dosage and Administration

take with a glass of water do not take more than directed adults and children 12 years of age and over 1-3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor

Description

Bisacodyl 5 mg

Section 44425-7

store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive humidity package not child resistant

Section 50565-1

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

Section 51727-6

acacia, ammonium hydroxide, calcium carbonate, corn starch, D & C yellow #10 lake, FD & C yellow #6 lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, PEG, polydextrose, polyvinyl acetate phthalate, propylparaben, propylene glycol, povidone, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Section 51945-4

1

Section 53413-1

1-800-540-3765

Section 55105-1

Stimulant Laxative

Section 55106-9

Bisacodyl 5 mg


Structured Label Content

Indications and Usage (34067-9)

for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)

take with a glass of water do not take more than directed adults and children 12 years of age and over 1-3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor

Warnings and Precautions (34071-1)

Do not use if you cannot swallow without chewing Ask a doctor before use if you have • stomach pain, nausea, vomiting • noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk • it may cause stomach discomfort, faintness and cramps 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.

Section 44425-7 (44425-7)

store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive humidity package not child resistant

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

acacia, ammonium hydroxide, calcium carbonate, corn starch, D & C yellow #10 lake, FD & C yellow #6 lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, PEG, polydextrose, polyvinyl acetate phthalate, propylparaben, propylene glycol, povidone, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Section 51945-4 (51945-4)

1

Section 53413-1 (53413-1)

1-800-540-3765

Section 55105-1 (55105-1)

Stimulant Laxative

Section 55106-9 (55106-9)

Bisacodyl 5 mg


Raw Label Data

All Sections (JSON)