Label: STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet
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NDC Code(s):
71335-1531-0,
71335-1531-1,
71335-1531-2,
71335-1531-3, view more71335-1531-4, 71335-1531-5, 71335-1531-6, 71335-1531-7, 71335-1531-8, 71335-1531-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57896-441
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 19, 2024
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
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Warnings
Do not use if you cannot swallow without chewing
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
Stop use and ask a doctor if • you have rectal bleeding or no
bowel movement after using this product.
These could be signs of a serious condition.
• you need to use a laxative for more than 1 week
If pregnant or breast-feeding, ask a health professional before use. - Directions
- Other information
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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 or comments?
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HOW SUPPLIED
NDC: 71335-1531-0: 25 Tablets in a BOTTLE
NDC: 71335-1531-1: 30 Tablets in a BOTTLE
NDC: 71335-1531-2: 2 Tablets in a BOTTLE
NDC: 71335-1531-3: 3 Tablets in a BOTTLE
NDC: 71335-1531-4: 4 Tablets in a BOTTLE
NDC: 71335-1531-5: 10 Tablets in a BOTTLE
NDC: 71335-1531-6: 90 Tablets in a BOTTLE
NDC: 71335-1531-7: 8 Tablets in a BOTTLE
NDC: 71335-1531-8: 100 Tablets in a BOTTLE
NDC: 71335-1531-9: 20 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STIMULANT LAXATIVE ENTERIC COATED
bisacodyl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-1531(NDC:57896-441) 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) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 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:71335-1531-0 25 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 2 NDC:71335-1531-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:71335-1531-2 2 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 4 NDC:71335-1531-3 3 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 5 NDC:71335-1531-4 4 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2020 6 NDC:71335-1531-5 10 in 1 BOTTLE; Type 0: Not a Combination Product 06/16/2020 7 NDC:71335-1531-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 8 NDC:71335-1531-7 8 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 9 NDC:71335-1531-8 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 10 NDC:71335-1531-9 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 01/01/2000 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-1531) , RELABEL(71335-1531)
