Label: STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet
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NDC Code(s):
57896-441-01,
57896-441-10,
57896-441-20,
57896-441-25, view more57896-441-26
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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
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Warnings
Do not use if you cannot swallow without chewing
Ask a doctor before use if you have
• stomach pain, nausea, vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product • do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps
Stop use and ask a doctor if • you have rectal bleeding or no
bowel movement after using this product.
These could be signs of a serious condition.
• you need to use a laxative for more than 1 week
If pregnant or breast-feeding, ask a health professional before use. - Directions
- Other information
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Inactive ingredients
acacia, ammonium hydroxide,
calcium carbonate, corn starch, D&C yellow #10 lake,
FD&C yellow #6 lake, hypromellose, iron oxide black, lactose,
magnesium stearate, methylparaben, PEG, polydextrose,
polyvinyl acetate phthalate, propylparaben, propylene glycol,
povidone, shellac, simethicone, silica, sodium alginate,
sodium benzoate, sodium bicarbonate, stearic acid, sucrose,
talc, titanium dioxide, triacetin, triethyl citrate, wax. - Questions or comments?
- Package Label
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INGREDIENTS AND APPEARANCE
STIMULANT LAXATIVE ENTERIC COATED
bisacodyl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-441 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 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) ACACIA (UNII: 5C5403N26O) AMMONIA (UNII: 5138Q19F1X) CALCIUM CARBONATE (UNII: H0G9379FGK) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:57896-441-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011 2 NDC:57896-441-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2016 3 NDC:57896-441-25 1 in 1 CARTON 07/01/2015 3 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:57896-441-26 25 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 5 NDC:57896-441-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 01/01/2000 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)
