Label: BISACODYL ENTERIC COATED- bisacodyl tablet, coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 58118-7927-0, 58118-7927-3, 58118-7927-6, 58118-7927-8, view more58118-7927-9 - Packager: Clinical Solutions Wholesale
- 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.
Drug Label Information
Updated July 1, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
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
-
INGREDIENTS AND APPEARANCE
BISACODYL ENTERIC COATED
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58118-7927(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:58118-7927-3 30 in 1 BOTTLE 2 NDC:58118-7927-6 60 in 1 BOTTLE 3 NDC:58118-7927-9 90 in 1 BOTTLE 4 NDC:58118-7927-8 30 in 1 BLISTER PACK 5 NDC:58118-7927-0 1 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/24/2008 Labeler - Clinical Solutions Wholesale (078710347) Registrant - Clinical Solutions Wholesale (078710347) Establishment Name Address ID/FEI Business Operations Clinical Solutions Wholesale 078710347 REPACK(58118-7927) , RELABEL(58118-7927)