Active Ingredient
Bisacodyl
10 mg per suppository.
Bisacodyl
10 mg per suppository.
The Magic Bullet
FDA Label NDC 57648-002
13 label sections · Submitted to the FDA by Concepts In Confidence · 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, do not use, use of this product, stop use and ask a doctor if, ask a doctor before use, keep this and all medication out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant
Laxative
Stimulant
Laxative
Use
rectally for relief of occasional constipation. This product generally produces a bowel movement within 15 minutes to one hour.
rectally for relief of occasional constipation. This product generally produces a bowel movement within 15 minutes to one hour.
Do Not Use
if presence nausea, vomiting, rectal bleeding, or in children under 5 years of age or for more than one week unless directed by a doctor.
if presence nausea, vomiting, rectal bleeding, or in children under 5 years of age or for more than one week unless directed by a doctor.
Use Of This Product
may cause abdominal discomfort, faintness, rectal burning and mild cramps.
may cause abdominal discomfort, faintness, rectal burning and mild cramps.
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.
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.
Frequent or continued use of this product may result in dependence on laxatives.
DRUG FACTS (continued)
If pregnant or breast feeding, or if a sudden change in bowel habits persists for more than two weeks.
Frequent or continued use of this product may result in dependence on laxatives.
DRUG FACTS (continued)
Keep This And All Medication Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 – 10 mg, one suppository, in a single daily dose. Children 6-12 – dosage – 5 mg, one-half suppository, in a single daily dose. Children under 6 – consult a doctor.
Remove plastic wrap and insert rounded end first into the rectum.
Adults and children over the age of 12 – dosage – 10 mg, one suppository, in a single daily dose. Children 6-12 – dosage – 5 mg, one-half suppository, in a single daily dose. Children under 6 – consult a doctor.
Other Information
Store below 86°F (30°C)
Store below 86°F (30°C)
Inactive Ingredients
Polyethylene glycol, propylene glycol diacetate.
Mfg. for Concepts in Confidence
Boynton Beach, FL 33426
(800) 822-4050
Rev 09/16
DRUG FACTS
Polyethylene glycol, propylene glycol diacetate.
Mfg. for Concepts in Confidence
Boynton Beach, FL 33426
(800) 822-4050
Rev 05/14
Principal Display Panel – 100 Suppositories
NDC 57648-002-01
100 SUPPOSITORIES
THE MAGIC BULLET™
LAXATIVE SUPPOSITORIES
EACH CONTAINING 10 mg BISACODYL USP
Contains No Hydrogenated Vegetable Oil
TAMPER RESISTANT: Individually Sealed For Your Protection
Ndc 57648-002-01 100 Suppositories The Magic Bullet™laxative Suppositorieseach Containing 10 mg Bisacodyl Uspcontains No Hydrogenated Vegetable Oil Tamper Resistant: Individually Sealed For Your Protection (The Magic Bullet 01)
Principal Display Panel – 10 Suppositories
NDC 57648-002-10
THE MAGIC BULLET™
LAXATIVE SUPPOSITORIES
EACH CONTAINING 10 mg BISACODYL USP
TAMPER RESISTANT:
INDIVIDUALLY SEALED FOR YOUR PROTECTION
Contains No Hydrogenated Vegetable Oil
10 SUPPOSITORIES
Concepts in Confidence
Ndc 57648-002-10 The Magic Bullet™laxative Suppositorieseach Containing 10 mg Bisacodyl Usptamper Resistant: Individually Sealed For Your Protectioncontains No Hydrogenated Vegetable Oil10 Suppositories Concepts In Confidence (The Magic Bullet 02)
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