Your browser does not support JavaScript! GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE (BISACODYL) TABLET [CARE ONE (AMERICAN SALES COMPANY)]
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GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE (bisacodyl) tablet
[Care One (American Sales Company)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient (in each enteric tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing.

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

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • 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 triacetin

‚ÄčQuestions or Comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in CORRECTOL® *

Gentle Laxative for Women

For gentle, dependable overnight relief 

Stimulant Laxative

Bisacodyl 5 mg

Tablets

*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

1-877-846-9949

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.

Product Label

Bisacodyl 5 mg

Care One Gentle Laxative For Women

GENTLE LAXATIVE FOR WOMEN  STIMULANT LAXATIVE
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL057
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-120-302 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/15/2010
Labeler - Care One (American Sales Company) (809183973)

Revised: 7/2014
 
Care One (American Sales Company)

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