Label: DULCOLAX STIMULANT LAXATIVE- bisacodyl tablet, coated
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NDC Code(s):
41167-0200-1,
41167-0200-2,
41167-0200-3,
41167-0200-4, view more41167-0200-5, 41167-0200-6, 41167-0200-8, 41167-0400-1, 41167-0400-2, 41167-0400-3, 41167-0400-4, 41167-0400-5, 41167-0400-6, 41167-0400-8, 41167-0400-9
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
● stomach pain, nausea or vomiting
● noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product
● it may cause stomach discomfort, faintness and cramps
● do not chew or crush tablet(s)
● do not use within 1 hour after taking an antacid or milk
- Directions
- Other information
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Inactive ingredients
acacia senegal gum, 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 oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
- Questions?
- Active ingredient (in each tablet)
- Purpose
- Use
-
Warnings
Ask a doctor before use if you have
● stomach pain, nausea or vomiting
● noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product
● it may cause stomach discomfort, faintness and cramps
● do not chew or crush tablet(s) ● do not use within 1 hour after taking an antacid or milk
- Directions
- Other information
-
Inactive ingredients
acacia senegal gum, 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 oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DULCOLAX STIMULANT LAXATIVE
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0400 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) STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHELLAC (UNII: 46N107B71O) 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) Product Characteristics Color orange Score no score Shape ROUND Size 5mm Flavor Imprint Code DL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0400-5 1 in 1 CARTON 04/14/2019 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41167-0400-6 8 in 1 CARTON 04/14/2019 2 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:41167-0400-8 3 in 1 CARTON 05/01/2019 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:41167-0400-3 2 in 1 CARTON 04/14/2019 4 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:41167-0400-2 1 in 1 CARTON 04/14/2019 5 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:41167-0400-1 1 in 1 CARTON 04/14/2019 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:41167-0400-4 4 in 1 CARTON 06/03/2019 7 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:41167-0400-9 1 in 1 CARTON 06/01/2022 8 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 04/14/2019 DULCOLAX STIMULANT LAXATIVE
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0200 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) STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHELLAC (UNII: 46N107B71O) 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) Product Characteristics Color orange Score no score Shape ROUND Size 5mm Flavor Imprint Code DL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0200-5 1 in 1 CARTON 02/25/2019 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41167-0200-6 8 in 1 CARTON 04/11/2019 2 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:41167-0200-8 3 in 1 CARTON 01/02/2019 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:41167-0200-3 2 in 1 CARTON 01/02/2019 4 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:41167-0200-2 1 in 1 CARTON 02/15/2019 5 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:41167-0200-1 1 in 1 CARTON 03/01/2019 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:41167-0200-4 4 in 1 CARTON 01/02/2019 7 25 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 01/02/2019 Labeler - Chattem, Inc. (003336013)