Label: BISACODYL tablet, coated
- NDC Code(s): 0904-6748-17, 0904-6748-60, 0904-6748-80
- 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 August 3, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- stomach pain, nausea or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
When using this product
- do not chew or crush tablet(s)
- do not use within 1 hour after taking an antacid or milk
- you may have stomach discomfort, faintness and cramps
- stomach pain, nausea or vomiting
- Directions
- Other information
-
Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
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Principal display panel
NDC 0904-6748-60
Compare to the active
ingredient in Dulcolax®
Laxative Tablets*Major®
Bisacodyl USP
5 mgStimulant Laxative
Gentle, Dependable
Constipation ReliefActual Size
100 TABLETS
Comfort Coated TabletsTAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by Sanofi-Aventis
Deutschland GMBH, owner of the registered trademark Dulcolax®
Laxative Tablets. 50844 REV0119B32712Distributed by
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
M-17 Rev. 06/21 Re-order No. 700928
Major 44-327
-
INGREDIENTS AND APPEARANCE
BISACODYL
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6748 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 YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) 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) AMMONIA (UNII: 5138Q19F1X) 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:0904-6748-17 1 in 1 CARTON 12/01/2018 1 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0904-6748-60 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2018 3 NDC:0904-6748-80 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/01/2018 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0904-6748) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(0904-6748) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0904-6748) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0904-6748) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0904-6748)