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Dulcolax by Physicians Total Care, Inc.

Dosage form: suppository
Ingredients: bisacodyl 10mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-3155

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.

Dulcolax® Suppository

Drug Facts
Active ingredient (in each suppository)Purpose
Bisacodyl USP 10 mg .................................... Stimulant laxative

Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only

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 it may cause stomach discomfort, faintness, rectal burning and mild 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 12 years of age and over1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age1/2 suppository in a single daily dose
children under 2 years of ageask a doctor

Other information
  • do not store above 30°C (86°F)

Inactive ingredient

hydrogenated vegetable oil

Dulcolax (bisacodyl USP) Laxative Suppositories

10 mg

NDC 54868-3155-1


DULCOLAX 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-3155(NDC:0597-0052)
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bisacodyl (bisacodyl) bisacodyl10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED COCONUT OIL 
HYDROGENATED PALM KERNEL OIL 
Product Characteristics
ColorWHITEScore    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-3155-14 BLISTER PACK (BLISTER PACK) in 1 CARTON
14 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/17/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 02/2011
 
Physicians Total Care, Inc.

See also...

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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