1. Home
  2. Labeler Index
  3. Graxcell Pharmaceutical, Llc
  4. 70795-1010
  5. Label Information: Laxative

FDA Label for Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR
    7. STOP USE AND ASK A DOCTOR
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. PRINCIPAL DISPLAY PANEL

Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Graxcell Pharmaceutical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



Table - T

Table - T

  • 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

Label 1 - 8

Label 1 - 8


* Please review the disclaimer below.