Search by Drug Name or NDC
NDC 00904-6981-12 Leader Gentle Laxative 10 mg/2000mg Details
Leader Gentle Laxative 10 mg/2000mg
Leader Gentle Laxative is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is BISACODYL.
MedlinePlus Drug Summary
Rectal bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 00904-6981-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl Rectal
Product Information
NDC | 00904-6981 |
---|---|
Product ID | 0904-6981_d5faa3f4-8e31-a9c2-e053-2995a90a27b6 |
Associated GPIs | 46200010005205 |
GCN Sequence Number | 002944 |
GCN Sequence Number Description | bisacodyl SUPP.RECT 10 MG RECTAL |
HIC3 | Q3S |
HIC3 Description | LAXATIVES, LOCAL/RECTAL |
GCN | 08731 |
HICL Sequence Number | 001301 |
HICL Sequence Number Description | BISACODYL |
Brand/Generic | Generic |
Proprietary Name | Leader Gentle Laxative |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Bisacodyl Suppository |
Product Type | HUMAN OTC DRUG |
Dosage Form | SUPPOSITORY |
Route | RECTAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/2000mg |
Substance Name | BISACODYL |
Labeler Name | Major Pharmaceuticals |
Pharmaceutical Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part334 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 00904-6981-12 (00904698112)
NDC Package Code | 0904-6981-12 |
---|---|
Billing NDC | 00904698112 |
Package | 1 BLISTER PACK in 1 CARTON (0904-6981-12) / 120 mg in 1 BLISTER PACK (0904-6981-13) |
Marketing Start Date | 2019-10-01 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.29334 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | BISACODYL 10 MG SUPPOSITORY |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 17cdd983-f114-4265-a9aa-42db609c7daf Details
Active Ingredient (in each Suppository)
Uses
Do not use
Ask a doctor
When using this product
Stop use and ask a doctor
Keep out of reach of children
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
INGREDIENTS AND APPEARANCE
LEADER GENTLE LAXATIVE
bisacodyl suppository suppository |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Major Pharmaceuticals (191427277) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Unipack, Inc. | 009248480 | manufacture(0904-6981) |