Active Ingredient
Bisacodyl 10mg per suppository
The Magic Bullet
FDA Label NDC 57648-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Concepts In Confidence for the product The Magic Bullet (NDC 57648-002). 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, purpose, use, warnings, do not use, stop use and ask a doctor if, ask a doctor before use if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulate Laxative
Use
rectally for relief of occasional constipation. This product generally produces bowel movement in 15 minutes to one hour.
Warnings
Use of this product may cause abdominal discomfort, faintness, rectal burning and mild cramps
Frequent or continued use of this product may result in dependence on laxatives.
Do Not Use
in the presence of nausea, vomiting, rectal bleeding, or in children under 6 years of age, or for more than one week unless directed by a doctor.
Stop Use And Ask A Doctor If
rectal bleeding occurs or if you fail to have a bowel movement after using a laxative. This may indicate a serious condition.
Ask A Doctor Before Use If
pregnant or breast feeding, or if a sudden change in bowel habits persists for more than two weeks.
Otc - Pregnancy Or Breast Feeding
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Keep This And All Medications Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Remove plastic wrap and insert rounded end first into the rectum. Adults and children over the age of 12 - dosage is 10 mg, one suppository, in a single daily dose. Children 6-12 - dosage is 5 mg, one-half suppository, in a single daily dose. Children under 6 - consult a doctor.
Other Information
Store below 86oF (30oC)
Inactive Ingredients
Polyethylene glycol, propylene glycol diacetate
* Please review the disclaimer below.
