Label: THE MEDICINE SHOPPE GENTLE LAXATIVE- bisacodyl tablet
- NDC Code(s): 49614-131-63
- Packager: The Medicine Shoppe International
- 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(s)
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 or 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 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
- each tablet contains: sodium less than 0.5mg
- store at 20°-25°C (68°-77°F)
- protect from excessive humidity
- TAMPER EVIDENT: Blister packaged for your protection. Do not use if individual seals are broken
- 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 dioxide.
- Principal Display Panel
The Medicine Shoppe
Overnight Relief of Constipation and Irregularity
*Compare to the active ingredient of Dulcolax®
Bisacodyl USP, 5 mg
25 Coated Tablets
The Medicine Shoppe International, Inc.
Earth City MO 63045
A Cardinal Health Company
- INGREDIENTS AND APPEARANCE
THE MEDICINE SHOPPE GENTLE LAXATIVE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49614-131 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 FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE POVIDONE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code TCL;003 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49614-131-63 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 10/14/2011 Labeler - The Medicine Shoppe International (071997654)