Label: BISACODYL ENTERIC COATED- bisacodyl tablet, coated
- NDC Code(s): 0904-7927-17, 0904-7927-60, 0904-7927-61, 0904-7927-80
- Packager: Major Pharmaceuticals
- 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 October 1, 2019
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- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Ask a doctor before use if
-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
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 or cramps
- Directions
- Other information
- Storage
- Inactive ingredients
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISACODYL ENTERIC COATED
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7927 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 SULFATE ANHYDROUS (UNII: E934B3V59H) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) 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:0904-7927-17 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 10/24/2008 07/31/2020 2 NDC:0904-7927-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/24/2008 05/31/2021 3 NDC:0904-7927-61 100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 10/24/2008 02/28/2018 4 NDC:0904-7927-80 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/24/2008 05/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/24/2008 05/31/2021 Labeler - Major Pharmaceuticals (191427277)