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Label: BISACODYL ENTERIC COATED- bisacodyl tablet, coated
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- 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 July 20, 2012
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours
Close - 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
Stop use and ask a doctor if
-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
-you need to use a laxative for more than 1 week
CloseKeep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
-take with a glass of water
adults and children 12 years and over- take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age - take 1 tablet in a single daily dose
children under 6 years of age - ask a doctor
Close - Other information
-store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)
-use by expiration date on package
-protect from excessive humidity
Close - Storage
- Inactive ingredients
acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.
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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) (BISACODYL - UNII:10X0709Y6I) 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 (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (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 2 NDC:0904-7927-60 100 in 1 BOTTLE 3 NDC:0904-7927-61 100 in 1 BOX, UNIT-DOSE 4 NDC:0904-7927-80 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 10/24/2008 CloseLabeler - Major Pharmaceuticals (191427277)
