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LAXATIVE by GRAXCELL PHARMACEUTICAL, LLC

Medically reviewed on June 15, 2017

Dosage form: suppository
Ingredients: BISACODYL 10mg
Labeler: GRAXCELL PHARMACEUTICAL, LLC
NDC Code: 70795-1010

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.

Active Ingredient (in each suppository)

Bisacodyl, 10  mg

Purpose

Stimulant Laxative

Uses
  • For relief of occasional constipation
  • This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only. ​May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Do not use
  • more than once per day
  • for a period longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomitting are present unless directed by a doctor
  • if sealed film around the suppository is torn, damaged, or open.

Ask a doctor
  • before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby

Stop use and ask a doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Detach one suppository from the strip and remove from foil
  • Carefully insert one supoository well into the rectum
  • Do not use more than once per day

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

Principal Display panel

GRAXCELL PHARMACEUTICAL, LLC.

NDC 70795-1010-8/70795-1010-5/70795-1010-1

*Compare to active ingredient in Dulcolax Suppositories

Laxative Suppositories Bisacodyl USP 10mg

For Relief of Occasional Constipation

Gentle and fast Relief

Relieves Constipation Often In 15 Minutes to 1 Hour

8 Comfort Shaped Suppositories

LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1010
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD 
Packaging
#Item CodePackage Description
1NDC:70795-1010-88 BLISTER PACK in 1 BOX
11 SUPPOSITORY in 1 BLISTER PACK
2NDC:70795-1010-550 BLISTER PACK in 1 BOX
21 SUPPOSITORY in 1 BLISTER PACK
3NDC:70795-1010-1100 BLISTER PACK in 1 PACKAGE
31 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/29/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
Registrant - GRAXCELL PHARMACEUTICAL, LLC (056556923)

 
GRAXCELL PHARMACEUTICAL, LLC

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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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