BISACODYL - bisacodyl suppository 
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient..........................................Bisacodyl USP, 10 mg

Inactive ingredients...............................................hydrogenated vegetable oil

Purpose .....................................................Laxative

Uses
for the relief of occasional constipation bowel movement is generally produced in 15 minutes to 1 hour

Warnings

For rectal use only

Do not use laxative products for a period longer than one week unless directed by a doctor
Ask a doctor before use if you have

  • . abdominal pain, nausea or vomiting
  • . a sudden change in bowel habits that lasts longer than 2 weeks

Stop use and ask a doctor if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • . see chart below for dose
  • . remove foil wrapper
  • . insert suppository well up into the rectum as indicated, and retain it about 15 to 20 minutes
Adults and children 12 years and over
1 suppository once daily
Children 6 years to under 12 years
1/2 suppository once daily
Children under 6 years
Ask a Doctor

  • . In the presence of anal fissures or hemorrhoids, suppositories should becoated at the tip with petroleum jelly.

HOW SUPPLIED

Bisacodyl USP, 10 mg Suppositories is supplied in

5 panel/box of 8NDC 54868-2039-1
box of 12
NDC 54868-2039-0


Store at room temperature 15°- 30°C (59°- 86°F).

Mfd. by: G & W Laboratories, Inc.; South Plainfield, NJ    07080


Relabeling of "Additional barcode" label by:
Physicians Total Care, Inc., Tulsa, OK      74146



PRINCIPAL DISPLAY PANEL

Bisacodyl USP, 10 mg Suppositories 

NDC 54868-2039-0

image of package label

BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2039(NDC:0713-0109)
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD 
Packaging
#Item CodePackage Description
1NDC:54868-2039-012 in 1 BOX
2NDC:54868-2039-18 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/04/200301/15/2013
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-2039)

Revised: 01/2013
 
Physicians Total Care, Inc.