LEADER GENTLE LAXATIVE- bisacodyl suppository suppository 
Major Pharmaceuticals

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Major ®Bisacodyl Medicated Laxative Suppositories 12 ct

Active Ingredient (in each Suppository)

                                                                   Purpose

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

Uses

Uses - For temporary relief of occasional constipation and irregularity

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

Warnings

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.

Directions

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

Purpose

Stimulant Laxative

Qutestions?

Questions? 1-724-733-7381

Product Label

Product Label

LEADER GENTLE LAXATIVE 
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
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg  in 2000 mg
Inactive Ingredients
Ingredient NameStrength
PALM KERNEL OIL (UNII: B0S90M0233)  
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6981-121 in 1 CARTON10/01/2019
1NDC:0904-6981-13120 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 DrugM00710/01/201901/01/2025
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(0904-6981)

Revised: 6/2024
Document Id: 1ad12b1c-e092-fd30-e063-6394a90a8f3c
Set id: 97a3a84f-a7cb-4db3-a40c-5932ef4e80ca
Version: 5
Effective Time: 20240614
 
Major Pharmaceuticals