Label: LAXATIVE GENTLE- bisacodyl tablet, delayed release
- NDC Code(s): 67091-215-25
- Packager: WinCo Foods, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 7, 2023
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- 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)
- you may have stomach discomfort, faintness and cramps
- Directions
- Other information
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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?
-
Principal Display Panel
WinCo®
FOODSGENTLE
LaxativeBISACODYL USP 5 mg/
STIMULANT LAXATIVE*Compare to the
active ingredient
in DULCOLAX®Easy to Swallow
Overnight Relief
25
Enteric Coated
TabletsTAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERINGDISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
*This product is not manufactured or distributed by SANOFI-AVENTIS
DEUTSCHLAND GMBH, distributor of DULCOLAX®.100% SATISFACTION GUARANTEE
Comments & Questions? 800-824-170650844 REV0119C32756 WF2107
Winco 44-327
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INGREDIENTS AND APPEARANCE
LAXATIVE GENTLE
bisacodyl tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-215 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:67091-215-25 1 in 1 CARTON 03/25/2002 1 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 - WinCo Foods, LLC (056098817) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(67091-215) , pack(67091-215) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(67091-215) , pack(67091-215) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(67091-215) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(67091-215) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(67091-215)