Label: DULCOLAX- bisacodyl tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 29485-6741-3 - Packager: Mechanical Servants, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0597-0012
- 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 January 6, 2012
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 (in each tablet)
- Purpose
- Use
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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
- it may cause stomach discomfort, faintness and cramps
- Directions
- Other information
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Inactive ingredients
acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package
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INGREDIENTS AND APPEARANCE
DULCOLAX
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29485-6741(NDC:0597-0012) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl 5 mg Inactive Ingredients Ingredient Name Strength acacia (UNII: 5C5403N26O) carnauba wax (UNII: R12CBM0EIZ) cellacefate (UNII: F2O5O2OI9F) starch, corn (UNII: O8232NY3SJ) dibutyl phthalate (UNII: 2286E5R2KE) docusate sodium (UNII: F05Q2T2JA0) gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) kaolin (UNII: 24H4NWX5CO) lactose (UNII: J2B2A4N98G) magnesium stearate (UNII: 70097M6I30) methylparaben (UNII: A2I8C7HI9T) shellac (UNII: 46N107B71O) polyethylene glycols (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) propylparaben (UNII: Z8IX2SC1OH) sodium benzoate (UNII: OJ245FE5EU) sorbitan monooleate (UNII: 06XEA2VD56) sucrose (UNII: C151H8M554) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) white wax (UNII: 7G1J5DA97F) diacetylated monoglycerides (UNII: 5Z17386USF) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color ORANGE Score no score Shape ROUND Size 5mm Flavor Imprint Code 12;BI Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29485-6741-3 1 in 1 PACKAGE 1 3 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/01/2010 Labeler - Mechanical Servants, Inc. (005530951) Establishment Name Address ID/FEI Business Operations Boehringer Ingelheim Promeco S.A. de C.V. 812579472 MANUFACTURE Establishment Name Address ID/FEI Business Operations Mechanical Servants, Inc. 005530951 RELABEL