Label: GENTLE LAXATIVE ENTERIC COATED- bisacodyl tablet, coated
- NDC Code(s): 49348-599-05
- Packager: McKesson (Sunmark)
- 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 tablet)
Bisacodyl, USP 5 mgClose
- for temporary relief of occasional constipation and irregularity
- this product generally produces a 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)
- do not use within 1 hour after taking an antacid or milk
- it may cause stomach discomfort, faintness and cramps
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 between 20º-25ºC (68º-77ºF)
- 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxideClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
COMPARE TO DULCOLAX® ACTIVE INGREDIENT*
For relief of occasional constipation
TABLETS 5 mg EACH
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.
Distributed By McKesson
One Post Street, San Francisco, CA 94104
Please visit us at www.sunmarkbrand.comClose
- Package Label
Sunmark Gentle Laxative Tablet
- INGREDIENTS AND APPEARANCE
GENTLE LAXATIVE ENTERIC COATED
bisacodyl tablet, coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-599 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 GELATIN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE Polyvinyl Acetate Phthalate SUCROSE POVIDONES FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE POLYETHYLENE GLYCOLS ALUMINUM OXIDE Product Characteristics Color ORANGE 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:49348-599-05 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 01/10/2013 Labeler - McKesson (Sunmark) (177667227)