Label: LEADER GENTLE LAXATIVE- bisacodyl suppository suppository
- NDC Code(s): 70000-0451-1, 70000-0451-4
- Packager: Cardinal Health, 110 dba LEADER
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 16, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each Suppository)
- Uses
- Warnings
- Do not use
- Ask a doctor
- When using this product
- Stop use and ask a doctor
- If pregnant or breast-feeding
- Keep out of reach of children
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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
- Inactive ingredient
- Purpose
- Qutestions?
- Product Label
-
INGREDIENTS AND APPEARANCE
LEADER GENTLE LAXATIVE
bisacodyl suppository suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0451 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 10 mg Inactive Ingredients Ingredient Name Strength PALM KERNEL OIL (UNII: B0S90M0233) Product Characteristics Color white Score Shape BULLET Size 32mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0451-1 1 in 1 CARTON 01/24/2019 1 NDC:70000-0451-4 4 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/24/2019 Labeler - Cardinal Health, 110 dba LEADER (063997360) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(70000-0451)