Leader Bisacodyl Suppositories

Leader Bisacodyl Suppositories
SPL v6
SPL
SPL Set ID c2b33e78-6ab7-1785-e053-2995a90a9c4f
Route
RECTAL
Published
Effective Date 2021-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (10 mg)
Inactive Ingredients
Hydrogenated Palm Kernel Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-19

Description

Bisacodyl USP, 10mg

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl USP, 10mg

Uses
  • for temporary relief of occasional constipation
  • this product generally produces bowel movement in 15 minutes to 1 hour
Warnings

For rectal use only.

Directions

  • detach one suppository from the strip
  • remove wrapper before inserting into rectum
  • carefully insert one suppository well into the rectum, pointed end first
  • retain about 15 to 20 minutes

adults and children 12 years of age and over - 1 suppository once daily

children 6 to under 12 years of age - 1/2 suppository once daily

children under 6 - do not use

Do Not Use
  • if abdominal pain, nausea or vomiting are present
  • for longer than 1 week
Other Information
  • Store at room remperature do not to exceed 30ºC (86ºF)
  • Lot No. & Exp. Date: see wrapper or box
Inactive Ingredients

hydrogenated vegetable oil

Questions Or Comments?

(800) 492-5988

When Using This Product

it may cause abdominal discomfort, faitness, rectal burning and mild cramps

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after using this product. These may indicate a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Leader Bisacodyl Suppositories

LeaderBisSupp.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Bisacodyl Suppositories

Distributed by

Major Pharmaceuticals

Livonia, MI 48152

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that lasts over a perios of 2 weeks

Active Ingredient (in Each Suppository)

Bisacodyl USP, 10mg


Structured Label Content

Uses
  • for temporary relief of occasional constipation
  • this product generally produces bowel movement in 15 minutes to 1 hour
Purpose

Stimulant Laxative

Warnings

For rectal use only.

Directions

  • detach one suppository from the strip
  • remove wrapper before inserting into rectum
  • carefully insert one suppository well into the rectum, pointed end first
  • retain about 15 to 20 minutes

adults and children 12 years of age and over - 1 suppository once daily

children 6 to under 12 years of age - 1/2 suppository once daily

children under 6 - do not use

Do Not Use (Do not use)
  • if abdominal pain, nausea or vomiting are present
  • for longer than 1 week
Other Information (Other information)
  • Store at room remperature do not to exceed 30ºC (86ºF)
  • Lot No. & Exp. Date: see wrapper or box
Inactive Ingredients (Inactive ingredients)

hydrogenated vegetable oil

Questions Or Comments? (Questions or comments?)

(800) 492-5988

When Using This Product (When using this product)

it may cause abdominal discomfort, faitness, rectal burning and mild 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 using this product. These may indicate a serious condition.

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.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Leader Bisacodyl Suppositories

LeaderBisSupp.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Bisacodyl Suppositories

Distributed by

Major Pharmaceuticals

Livonia, MI 48152

Ask A Doctor Before Use If You Have (Ask a Doctor before use if you have)

noticed a sudden change in bowel habits that lasts over a perios of 2 weeks

Active Ingredient (in Each Suppository) (Active ingredient (in each suppository))

Bisacodyl USP, 10mg


Advanced Ingredient Data


Raw Label Data

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