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Name:Bisacodyl
Manufacturer:Physicians Total Care, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


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 8 NDC 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2039(NDC:0713-0109)
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (BISACODYL) BISACODYL 10 mg
Inactive Ingredients
Ingredient Name Strength
FAT, HARD  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2039-0 12 SUPPOSITORY ( SUPPOSITORY) in 1 BOX None
2 NDC:54868-2039-1 8 SUPPOSITORY ( SUPPOSITORY) in 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/04/2003

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 03/2011 Physicians Total Care, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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