Label: LAXATIVE- bisacodyl tablet, coated
- NDC Code(s): 55315-190-03
- Packager: Freds 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.
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- Active ingredient (in each enteric coated tablet)
Bisacodyl, USP 5 mgClose
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
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)
- it may cause stomach discomfort, faintness and cramps
do not use within 1 hour after taking an antacid or milk
Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
take with a glass of water
adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor
- Other information
- store at controlled room temperature 15o- 30o C (59o- 86o F)
- Inactive ingredients
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C Yellow #10 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, and titanium dioxideClose
- Questions or Comments?
Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
*Compare to the active ingredient in DULCOLAX®
*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, owner of the registered trademark Dulcolax®
Bisacodyl, USP 5 mg
Gentle, Predictable Overnight relief from constipation
EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Bisacodyl 5 mg tablets
- INGREDIENTS AND APPEARANCE
bisacodyl tablet, coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-190 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (BISACODYL) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 ALUMINUM OXIDE GELATIN FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 Polyvinyl Acetate Phthalate POVIDONES SHELLAC SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE SUCROSE Product Characteristics Color ORANGE, YELLOW Score no score Shape ROUND Size 6mm Flavor Imprint Code TCL003 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-190-03 1 in 1 CARTON 1 25 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/08/2010 Labeler - Freds Inc (005866116) Registrant - P and L Development of New York Corporation (800014821)