Label: BISACODYL ENTERIC COATED- bisacodyl tablet, coated
- NDC Code(s): 67544-655-04, 67544-655-06
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-7927
- 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.
Updated December 23, 2019
If you are a consumer or patient please visit this version.
- Active ingredient(s)
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
Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.
- Inactive ingredients
Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 4mg 04 67544-655-04 06 67544-655-06
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Cookeville, TN 38506
- PRINCIPAL DISPLAY PANEL - 5mg
INGREDIENTS AND APPEARANCE
BISACODYL ENTERIC COATED
bisacodyl tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67544-655(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:67544-655-04 04 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2010 2 NDC:67544-655-06 06 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/29/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 10/24/2008 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 Repack(67544-655)