Label: GENTLE LAXATIVE- bisacodyl tablet, delayed release
- NDC Code(s): 70000-0221-1, 70000-0221-2, 70000-0221-3
- Packager: Cardinal Health 110, LLC. DBA Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- stomach pain, nausea or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
When using this product
- do not use within 1 hour after taking an antacid or milk
- do not chew or crush tablet(s)
- it may cause stomach discomfort, faintness, and cramps
- Directions
- Other information
-
Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
- Questions or comments?
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Principal Display Panel
NDC 70000-0221-3
LEADER™
Gentle
Laxative
Bisacodyl USP, 5 mg | Stimulant LaxativeGentle, Dependable
Constipation Relief175 ENTERIC COATED
TABLETSActual Size
COMPARE TO
DULCOLAX®
LAXATIVE TABLETS
active ingredient*100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by A. Nattermann
& Cie. GmbH, owner of the registered trademark Dulcolax®
Laxative Tablets. 50844 REV0923B32733DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979© 2023 Cardinal Health. All Rights
Reserved. CARDINAL HEALTH, the
Cardinal Health LOGO, LEADER, and
the Leader LOGO are trademarks or
registered trademarks of Cardinal
Health. All other marks are the
property of their respective
owners.All LEADERTM Brand
Products Have A
100%
Money Back
Guarantee
Return to place of
purchase if not satisfied.Leader 44-327
-
INGREDIENTS AND APPEARANCE
GENTLE LAXATIVE
bisacodyl tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0221 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) AMMONIA (UNII: 5138Q19F1X) CALCIUM CARBONATE (UNII: H0G9379FGK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color orange Score no score Shape ROUND Size 6mm Flavor Imprint Code 5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0221-1 1 in 1 CARTON 03/25/2002 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70000-0221-2 1 in 1 CARTON 03/25/2002 2 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:70000-0221-3 7 in 1 CARTON 03/25/2002 3 25 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 Drug 505G(a)(3) 03/25/2002 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(70000-0221) , pack(70000-0221) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(70000-0221) , pack(70000-0221) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(70000-0221) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0221) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(70000-0221)