Label: WOMENS GENTLE LAXATIVE- bisacodyl tablet
- NDC Code(s): 11673-151-52
- Packager: TARGET CORPORATION
- 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 April 16, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Acacia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Red #27 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow (Iron Oxide Ochre), Magnesium Stearate,Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalate, Povidone,Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warning: Do not use if you cannot swallow without chewing.
Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.
When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomack discomfort, faintness or cramps.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WOMENS GENTLE LAXATIVE
bisacodyl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-151 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) RAW SUGAR (UNII: 8M707QY5GH) ACACIA (UNII: 5C5403N26O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STEARIC ACID (UNII: 4ELV7Z65AP) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) FERROUS OXIDE (UNII: G7036X8B5H) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape ROUND Size 5mm Flavor Imprint Code TCL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-151-52 25 in 1 CARTON; Type 0: Not a Combination Product 04/26/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/01/2019 Labeler - TARGET CORPORATION (006961700) Registrant - TIME CAP LABORATORIES, INC. (037005209) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC 037052099 manufacture(11673-151)
