Label: BISACODYL tablet, delayed release
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NDC Code(s):
71335-2010-0,
71335-2010-1,
71335-2010-2,
71335-2010-3, view more71335-2010-4, 71335-2010-5, 71335-2010-6, 71335-2010-7, 71335-2010-8, 71335-2010-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0904-6748
- Category: HUMAN OTC DRUG LABEL
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 March 24, 2023
If you are a healthcare professional or from the pharmaceutical industry 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
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 chew or crush tablet(s)
- do not use within 1 hour after taking an antacid or milk
- you may have stomach discomfort, faintness and cramps
- stomach pain, nausea or vomiting
- 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 or comments?
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HOW SUPPLIED
NDC: 71335-2010-0: 25 Tablets in a BOTTLE
NDC: 71335-2010-1: 30 Tablets in a BOTTLE
NDC: 71335-2010-2: 2 Tablets in a BOTTLE
NDC: 71335-2010-3: 3 Tablets in a BOTTLE
NDC: 71335-2010-4: 4 Tablets in a BOTTLE
NDC: 71335-2010-5: 10 Tablets in a BOTTLE
NDC: 71335-2010-6: 90 Tablets in a BOTTLE
NDC: 71335-2010-7: 8 Tablets in a BOTTLE
NDC: 71335-2010-8: 100 Tablets in a BOTTLE
NDC: 71335-2010-9: 20 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BISACODYL
bisacodyl tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-2010(NDC:0904-6748) 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) 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) AMMONIA (UNII: 5138Q19F1X) 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:71335-2010-0 25 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 2 NDC:71335-2010-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 3 NDC:71335-2010-2 2 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 4 NDC:71335-2010-3 3 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 5 NDC:71335-2010-4 4 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 6 NDC:71335-2010-5 10 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 7 NDC:71335-2010-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 8 NDC:71335-2010-7 8 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 9 NDC:71335-2010-8 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 10 NDC:71335-2010-9 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/01/2018 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-2010) , RELABEL(71335-2010)