Label: WOMANS LAXATIVE- bisacodyl tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 37012-120-30 - Packager: Shopko Stores Operating Co., LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 March 20, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each enteric coated tablet)
- Purpose
- Use
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Warnings
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for longer than 1 week, unless directed by a doctor. Prolonged or continued use of this product can lead to laxative dependency and loss of normal bowel function. Serious side effects from prolonged use or overdose can occur
Caution
- do not chew or crush
- do not give to children under 6 years of age or to persons who cannot swallow without chewing
- do not take this product within 1 hour after taking an antacid and/or milk
- this product may cause abdominal discomfort, faintness, rectal burning, and mild cramps
Ask a doctor before use if
- you notice a sudden change in bowel habits that persists over a period of 2 weeks.
- Directions
- Other information
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Inactive ingredients
acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C Red #7 Calcium Lake, hypromellose phthalate, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, and triacetin
- Principal Display Panel
- PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
WOMANS LAXATIVE
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-120 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) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 7 (UNII: ECW0LZ41X8) HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONES (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color PINK Score no score Shape ROUND Size 11mm Flavor Imprint Code TCL057 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-120-30 2 in 1 CARTON 1 15 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/09/2010 Labeler - Shopko Stores Operating Co., LLC. (023252638) Registrant - P and L Development of New York Corporation (800014821)