Assured 44-327

Assured 44-327
SPL v4
SPL
SPL Set ID ec34fc1e-d122-4fa4-859e-e89e3e12edd5
Route
ORAL
Published
Effective Date 2019-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Ammonia Calcium Carbonate Carnauba Wax Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Ferrosoferric Oxide Anhydrous Lactose Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Povidone Propylene Glycol Propylparaben Sodium Alginate Sodium Benzoate Sodium Bicarbonate Stearic Acid Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate Silicon Dioxide Dimethicone

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-03-25

Description

Bisacodyl USP 5 mg

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl USP 5 mg

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Directions
  • take with a glass of water

Adults and children 12 years of age and over: 1 to 3 tablets in a single dose, once daily

Children 6 to under 12 years of age: take 1 tablet once daily

Children under 6 years of age: consult a doctor

Do Not Use

if you cannot swallow without chewing

Other Information
  • store between 68º to 77ºF (20º to 25ºC)

  • do not use if blister unit is broken or torn

Inactive Ingredients

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

Principal Display Panel
Laxative


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 and 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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Bisacodyl USP 5 mg

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Structured Label Content

Uses
  • for temporary 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

Adults and children 12 years of age and over: 1 to 3 tablets in a single dose, once daily

Children 6 to under 12 years of age: take 1 tablet once daily

Children under 6 years of age: consult a doctor

Do Not Use (Do not use)

if you cannot swallow without chewing

Other Information (Other information)
  • store between 68º to 77ºF (20º to 25ºC)

  • do not use if blister unit is broken or torn

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (Principal display panel)
Laxative


When Using This Product (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 and cramps
Stop Use and Ask A Doctor If (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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional 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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl USP 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)