BISACODYL

Main information

  • Trade name:
  • BISACODYL - bisacodyl suppository
  • Composition:
  • Bisacodyl 10 mg
  • Administration route:
  • RECTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BISACODYL - bisacodyl suppository
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Laxative For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 37205-102-53
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

BISACODYL - bisacodyl suppository

CARDINAL HEALTH, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bisacodyl Suppositories

ACTIVE INGREDIENT (in each suppository)

Bisacodyl USP, 10 mg

PURPOSE

Laxative

USES

For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1

hour.

WARNINGS

For rectal use only

Do not use

laxative products for a period longer than one week unless directed by a doctor

Ask a doctor before use if you have

abdominal pain, nausea or vomiting

a sudden change in bowel habits that lasts longer than 2 weeks

Stop use and ask a doctor

if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. This may indicate

a serious condition.

IF PREGNANT OR BREAST FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Remove foil. Insert suppository well into rectum touching the bowel wall. Retain about 15 to 20

minutes.

In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with

In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with

petroleum jelly.

OTHER INFORMATION

Store at room temperature

INACTIVE INGREDIENT

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-102-53

LEADER®

BISACODYL SUPPOSITORIES

LAXATIVE

FOR PROMPT RELIEF OF CONSTIPATION

12 BISACODYL SUPPOSITORIES 10 MG EACH

Compare to Dulcolax® active ingredient*

Satisfaction Guaranteed

BISACODYL

bisacodyl suppository

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:3720 5-10 2

Route of Administration

RECTAL

CARDINAL HEALTH, INC.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Bisa co dyl (UNII: 10 X0 70 9 Y6 I) (Bisaco dyl - UNII:10 X0 70 9 Y6 I)

Bisa c o dyl

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Hydro g ena ted Pa lm Kernel O il (UNII: FM8 D1RE2VP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:3720 5-10 2-53

12 in 1 CARTON

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 9 /10 /19 9 7

Labeler -

CARDINAL HEALT H, INC. (097537435)

Registrant -

G&W Laboratories, Inc. (001271188)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

G&W Labo rato ries, Inc.

0 0 127118 8

MANUFACTURE

Revised: 3/2012