Laxative
FDA Label NDC 63868-328

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Laxative (NDC 63868-328). 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 drug facts active ingredient, purpose, keep out of reach of children, uses, do not use, ask a doctor, stop use and ask a doctor, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts Active Ingredient

Active ingredient (in each Suppository)

Bisacodyl, 10 mg

Purpose

Stimulant Laxative

Keep Out Of Reach Of Children

Keep out of reach of children.

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

Uses

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

Do Not Use

  • more than once per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting 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 persists 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.

Directions




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

Other Information

  • Store at room temperature: 15° - 30° C (59° - 86° F) Do not exceed 30° C (86° F)
  • Individually sealed for your protection. Do not use if foil is torn or open.

Inactive Ingredients

hydrogenated vegetable oil

Warnings

For rectal use only.


May cause abdominal discomfort, faintness, rectal burning, and mild cramps.


Laxative Suppositories Product Label

For Relief of Occasional Constipation

NDC 63868-328-08

*Compare to the active ingredient in  Dulcolax®

QC QUALITY CHOICE

Laxative
Suppositories

Gentle and Fast Relief

Bisacodyl USP 10 mg
Relieves Constipation Often in 15 Minutes to 1 Hour

8 Comfort Shaped Suppositories

SATISFACTION GUARANTEED QC 100%

Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

TAMPER EVIDENT: Individually sealed in foil for your protection. Do not use if torn or open.

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, Inc., owner of the registered trademark Dulcolax®


* Please review the disclaimer below.