LAXATIVE- bisacodyl tablet, coated 
Freds Inc

Disclaimer: 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.

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DRUG FACTS

Active ingredient (in each enteric coated tablet)

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative

Use

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 that lasts more than 2 weeks

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and 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

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

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 (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

Questions or Comments?

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

Principal Display Panel

*Compare to the active ingredient in DULCOLAX®

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, owner of the registered trademark Dulcolax®

LAXATIVE TABLETS

Bisacodyl, USP 5 mg

Gentle, Predictable Overnight relief from constipation

EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Freds Inc.,

Bisacodyl 5 mg tablets

LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-190
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
ALUMINUM OXIDE 
GELATIN 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
Polyvinyl Acetate Phthalate 
POVIDONES 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
SUCROSE 
Product Characteristics
ColorORANGE, YELLOWScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-190-031 in 1 CARTON
125 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/08/2010
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013
Document Id: ff266c31-ddbe-4ba1-b82f-ffadae234850
Set id: af168dda-433b-4c0b-9b2d-65ca6b4d818b
Version: 1
Effective Time: 20130213
 
Freds Inc