Label: BISACODYL STIMULANT LAXATIVE- bisacodyl tablet, coated
- NDC Code(s): 68163-116-25
- Packager: Raritan Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 22, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
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- stomach pain, nausea or vomiting
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- a sudden change in bowel habits that lasts more than 2 weeks
When using this product
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- it may cause stomach discomfort, faintness and cramps
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- do not chew or crush tablet(s)
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- do not use within 1 hour after taking an antacid or milk
- Directions
- Other information
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Inactive ingredients
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.
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Principal Display Panel
NDC# 68163-116-25
*Compare to the Active Ingredient in Dulcolax® Tablets
Bisacodyl Laxative
Bisacodyl, USP 5 mg/Stimulant Laxative
Gentle, Overnight relief constipation relief
25 Coated Tablets
*This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets.
TAMPER EVIDENT: Do not use if any individual unit is broken or open.
IMPORTANT: Keep this carton for future reference on full labeling.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
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INGREDIENTS AND APPEARANCE
BISACODYL STIMULANT LAXATIVE
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-116 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 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, UNSPECIFIED (UNII: 2G86QN327L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) RAW SUGAR (UNII: 8M707QY5GH) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code RP116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-116-25 1 in 1 CARTON 10/29/2019 1 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 M007 10/29/2019 Labeler - Raritan Pharmaceuticals Inc (127602287)