Label: FLEET- bisacodyl tablet
- NDC Code(s): 0132-0704-02
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 24, 2013
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- Active Ingredient (in each tablet)
Bisacodyl 5 mg.......................Stimulant LaxativeClose
For relief of occasional constipation.Close
May cause abdominal discomfort, faintness and cramps.
If pregnant or breast-feeding, ask a health professional before use.
Ask a doctor before using any laxative if you have
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Do not take within 1 hour after taking an antacid, milk or milk products.
- Stop using this product and consult a doctor if you
- have rectal bleeding
- have no bowel movement after use
These symptoms may indicate a serious condition.Close
- Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.Close
Single Daily Dosage
adults and children 12 years and over
1 - 3 tablets
children 6 to under 12 years
children under 6 years
ask a doctor
- Other Information
- this product generally produces bowel movement in 6-12 hours
- each tablet is imprinted with "TCL 0003" for identification
- store at temperatures not above 86F (30C)
- do not use if foil imprinted with "Bisacodyl 5mg Laxative Tablet" is broken or missing
- consult Physicians' Desk Reference for complete professional labeling
- Inactive Ingredients
acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, collodial silicon dioxide, corn starch, DandC yellow 10 lake, FDandC yellow 6 lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sucrose, talc, titanium dioxideClose
1-866-255-6960 or www.fleetlabs.comClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0704 Route of Administration ORAL DEA Schedule 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) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM SULFATE (UNII: WAT0DDB505) 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 (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 24mm Flavor Imprint Code TCL003 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0704-02 25 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/05/2002 Labeler - C.B. Fleet Company, Inc. (003119054)