BISACODYL - bisacodyl suppository 
Cardinal Health

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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Leader Bisacodyl Suppositories

Active ingredient (in each suppository)

Bisacodyl USP, 10mg

Purpose

Stimulant Laxative

Uses

Warnings

For rectal use only.

Do not use unless directed by a doctor

  • if abdominal pain, nausea or vomiting are present
  • for longer than 1 week

Ask a Doctor before use if you have

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

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.

Directions

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

Other information

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

(800) 492-5988

Leader Bisacodyl Suppositories

LeaderBisSupp.jpg

Leader Bisacodyl Suppositories

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

BISACODYL  
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0573
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0573-24 in 1 CARTON05/19/2021
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70000-0573-11 in 1 CARTON05/19/2021
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/19/2021
Labeler - Cardinal Health (063997360)
Registrant - DSC Laboratories, Inc. (097807374)
Establishment
NameAddressID/FEIBusiness Operations
DSC Laboratories, Inc.097807374manufacture(70000-0573)

Revised: 6/2021
Document Id: c4f7dbbc-66e0-ad42-e053-2a95a90aba98
Set id: c2b33e78-6ab7-1785-e053-2995a90a9c4f
Version: 2
Effective Time: 20210617
 
Cardinal Health