Label: BISACODYL tablet, coated
-
NDC Code(s):
71335-1750-0,
71335-1750-1,
71335-1750-2,
71335-1750-3, view more71335-1750-4, 71335-1750-5, 71335-1750-6, 71335-1750-7, 71335-1750-8, 71335-1750-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 69618-058
- Category: HUMAN OTC DRUG LABEL
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 February 24, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Ask a doctor before use if you have
- stomach pain, nausea, vomiting
- noticed 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
- it may cause stomach discomfort, faintness and cramps
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients: Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D&C Yellow #10 Lake, FD&C Yellow #6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate,
Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin,Triethyl Citrate, Wax. - QUESTIONS
- SPL UNCLASSIFIED SECTION
-
HOW SUPPLIED
NDC: 71335-1750-0: 25 Tablets in a BOTTLE
NDC: 71335-1750-1: 30 Tablets in a BOTTLE
NDC: 71335-1750-2: 2 Tablets in a BOTTLE
NDC: 71335-1750-3: 3 Tablets in a BOTTLE
NDC: 71335-1750-4: 4 Tablets in a BOTTLE
NDC: 71335-1750-5: 10 Tablets in a BOTTLE
NDC: 71335-1750-6: 90 Tablets in a BOTTLE
NDC: 71335-1750-7: 8 Tablets in a BOTTLE
NDC: 71335-1750-8: 100 Tablets in a BOTTLE
NDC: 71335-1750-9: 20 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BISACODYL
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-1750(NDC:69618-058) 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 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) ACACIA (UNII: 5C5403N26O) AMMONIA (UNII: 5138Q19F1X) CALCIUM CARBONATE (UNII: H0G9379FGK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:71335-1750-0 25 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 2 NDC:71335-1750-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 3 NDC:71335-1750-2 2 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 4 NDC:71335-1750-3 3 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 5 NDC:71335-1750-4 4 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 6 NDC:71335-1750-5 10 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 7 NDC:71335-1750-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 8 NDC:71335-1750-7 8 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 9 NDC:71335-1750-8 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 10 NDC:71335-1750-9 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2020 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-1750) , RELABEL(71335-1750)