Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ccffcdc2-e065-40c3-bebb-051611694552
Route
ORAL
Published
Effective Date 2012-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bisacodyl (5 mg)
Inactive Ingredients
Acacia Carnauba Wax Starch, Corn Gelatin Hypromellose Phthalate (24% Phthalate, 55 Cst) Lactose Monohydrate Magnesium Stearate Polyethylene Glycol 400 Povidone Calcium Carbonate Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: BIS Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-02-15

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

Warnings

Do not use if you cannot swallow without chewing

Directions

take with a glass of water

adults and children 12 years of age and over

1 to 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

Package Label

Gentle Laxative

Other Information
  • store at 20° - 25°C (68° - 77°F)
  • protect from excessive humidity
  • blister packaged for your protection. Do not use if individual seals are broken.

Inactive Ingredients

acacia, carnauba wax, corn starch, gelatin, glycerin esters of fatty acids, hypromellose phthalate 200731, lactose hydrate, magnesium stearate, polyethylene glycol 400, povidone, precipitated calcium carbonate, sucrose, talc, titanium oxide, yellow no. 4

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.

Keep Out of Reach of Children,

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

Active Ingredient (in Each Tablet)

Bisacodyl USP 5 mg

Ask A Doctor Before Use If You Have
  • stomach 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

Warnings

Do not use if you cannot swallow without chewing

Directions

take with a glass of water

adults and children 12 years of age and over

1 to 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

Package Label (Package label)

Gentle Laxative

Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • protect from excessive humidity
  • blister packaged for your protection. Do not use if individual seals are broken.

Inactive Ingredients (Inactive ingredients)

acacia, carnauba wax, corn starch, gelatin, glycerin esters of fatty acids, hypromellose phthalate 200731, lactose hydrate, magnesium stearate, polyethylene glycol 400, povidone, precipitated calcium carbonate, sucrose, talc, titanium oxide, yellow no. 4

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
  • it may cause stomach discomfort, faintness and cramps

Stop Use and Ask A Doctor If (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, (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 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)
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks


Advanced Ingredient Data


Raw Label Data

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