Label: GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE- bisacodyl tablet
- NDC Code(s): 41520-120-30
- Packager: Care One (American Sales Company)
- 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 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 hat 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
- each tablet contains: calcium 15 mg
- store between 20º-25ºC (68º-77ºF)
- Inactive ingredients
acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C red # 7 calcium lake, hypromellose phthalate, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, and triacetinClose
- Questions or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Compare to the active ingredient in CORRECTOL® *
Gentle Laxative for Women
For gentle, dependable overnight relief
Bisacodyl 5 mg
*This product is not manufactured or distributed by MSD Consumer Care Inc., distributor of Correctol®.
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
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.Close
- Product Label
Care One Gentle Laxative For Women
- INGREDIENTS AND APPEARANCE
GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-120 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 CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C RED NO. 7 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW KAOLIN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONES SHELLAC SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN Product Characteristics Color PINK Score no score Shape ROUND Size 11mm Flavor Imprint Code TCL057 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-120-30 2 in 1 CARTON 1 15 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/15/2010 Labeler - Care One (American Sales Company) (809183973)