Laxative Suppository
FDA Label NDC 70795-1010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Graxcell Pharmaceutical, Llc for the product Laxative (NDC 70795-1010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each suppository), purpose, uses, warnings, do not use, ask a doctor, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Label 2 (5)

Label 2 (5)

Label 3 (1)

Label 3 (1)

* Please review the disclaimer below.