441

441
SPL v9
SPL
SPL Set ID c3fa1050-bb8b-449c-89e6-f5fd508278d2
Route
oral
Published
Effective Date 2013-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (5 mg)
Inactive Ingredients
sodium alginate sodium benzoate sodium bicarbonate stearic acid sucrose talc titanium dioxide triacetin triethyl citrate acacia ammonia calcium carbonate carnauba wax starch, corn d&c yellow no. 10 fd&c yellow no. 6 hypromelloses ferrosoferric oxide lactose monohydrate magnesium stearate methylparaben polydextrose polyethylene glycol, unspecified polyvinyl acetate phthalate propylparaben propylene glycol povidone shellac dimethicone silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
otc monograph drug active Since 2000-01-01

Purpose

Stimulant Laxative

Description

Bisacodyl 5 mg


Medication Information

Warnings

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.

Active Ingredient

Bisacodyl 5 mg

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

Stimulant Laxative

Directions
  • take with a glass of water
  • do not take more than directed
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 and under: ask a doctor
Other Information
  • 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
Inactive Ingredients

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.

Description

Bisacodyl 5 mg

Section 50565-1

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

Package Label

Questions Or Comments?

1-800-540-3765


Structured Label Content

Warnings

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.

Active Ingredient (Active ingredient (in each tablet))

Bisacodyl 5 mg

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

Stimulant Laxative

Directions
  • take with a glass of water
  • do not take more than directed
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 and under: ask a doctor
Other Information (Other information)
  • 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
Inactive Ingredients (Inactive ingredients)

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 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.

Package Label

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)