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 coated tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

  •  for relief of occasional constipation (irregularity)
  •  this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

in children under 6 years of age

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

unable to swallow without chewing

When using this product

  •  do not chew or crush tablets
  • do not use within 1 hour after taking an antacid or milk
  • abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

  •  you need to use more than 1 week
  • rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These maybe signs of serious condition.

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

  •  each tablet works differently. Adults and children over 12 may need fewer tablets to get the same effect as more tablets of another brand
  • start with one tablet and take with water. If one tablet does not produce the desired results, then try two or three tablets daily.
  • do not take more than 3 tablets daily
 adults and children 12 years of age and older take 1 to 3 tablets in a single dose once daily
 children 6 to under 12 years of age take 1 tablet once daily
 children under 6 years of age Ask a doctor

Other information

  • each tablet contains: calcium 15 mg
  • store between 15o - 30o C (59o- 86o F)
  • keep in a dry place
  • *This product is not manufactured or distributed by Schering- Plough, owner of the registered trademark Correctol®. 

Inactive ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C Red # 7 Calcium lake, hypromellose pthalate, 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

Principal Display Panel

Compare to the active ingredient in CORRECTOL® *

Gentle Laxative for Women

For gentle, dependable overnight relief 

Stimulant Laxative

Bisacodyl 5 mg

Distributed by: American Sales Company

4201 walden avenue, Lancaster NY 14086

www.care1.com

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCTS INFORMATION

Product Label

Careone stimulant laxative

Bisacodyl 5 mg

GENTLE LAXATIVE FOR WOMEN  STIMULANT LAXATIVE
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 56da0a39-2413-44ed-bca5-aca355fb1317
Set id: 1e9f02f7-d672-4f2e-a341-e5975b312d4b
Version: 1
Effective Time: 20121226
 
Care One (American Sales Company)

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