LEADER GENTLE LAXATIVE- bisacodyl suppository suppository 
Major Pharmaceuticals

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.


Major ® Bisacodyl Medicated Suppositories 100 ct

Active Ingredient (in each Suppository)


Bisacodyl USP, 10 mg.................................Stimulant Laxative


Uses - For temporary relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour


For rectal use only.

Do not use

Do not use - more than once per day  - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor- for a period of longer than one week unless directed by a doctor 

Ask a doctor

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative.  This 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 right away. (1-800-222-1222) right away.


Adults and children 12 years of age and older              Children 6 to under 12 years                 Children under 6

One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum, pointed end first

- Retain about 15 to 20 minutes

Other information

Other information - Storage temperature: not to exceed 30 oC (86 oF)

- Lot No. & Exp. Date: see wrapper or box

Inactive ingredient

Inactive ingredient  Hydrogenated vegetable oil


Stimulant Laxative


Questions? 1-724-733-7381

Product Label


bisacodyl suppository suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6981
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
PALM KERNEL OIL (UNII: B0S90M0233) 1990 mg  in 2000 mg
Product Characteristics
FlavorImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6981-601 in 1 CARTON10/17/2019
11000 mg 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 finalpart33410/01/2019
Labeler - Major Pharmaceuticals (191427277)
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(0904-6981)

Revised: 1/2022
Document Id: d5faa3f4-8e31-a9c2-e053-2995a90a27b6
Set id: 17cdd983-f114-4265-a9aa-42db609c7daf
Version: 3
Effective Time: 20220119
Major Pharmaceuticals