Label: BISACODYL 5MG tablet, coated
- NDC Code(s): 69168-398-92
- Packager: Allegiant Health
- 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 March 26, 2019
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- 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 are unable to swallow without chewing
- within 1 hour after taking an antacid or milk
Ask a doctor before use if you have
- abdominal pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When using this product
- do not chew or crush tablets
- abdominal discomfort, faintness, and cramps may occur
- Directions
- Other information
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Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl acetate pthalate, polydextrose, polyethylene glycol, propylparaben, propylene glycol, povidone, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISACODYL 5MG
bisacodyl 5mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-398 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 RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) 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 PINK Score no score Shape ROUND Size 5mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-398-92 1 in 1 CARTON 12/23/2014 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 NOT FINAL part334 12/23/2014 Labeler - Allegiant Health (079501930)