Label: THE MAGIC BULLET- bisacodyl suppository

  • NDC Code(s): 57648-002-01, 57648-002-10
  • Packager: Concepts in Confidence
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 4, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Bisacodyl
    10 mg per suppository.

  • Purpose

    Stimulant 
    Laxative

  • Use 

    rectally for relief of occasional constipation. This product generally produces a bowel movement within 15 minutes to one hour.

  • Warnings

    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.

    Use of this product

    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.

    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)

    Keep this and all medication 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 – 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)

  • Inactive ingredients

    Polyethylene glycol, propylene glycol diacetate.

    Mfg. for Concepts in Confidence

    Boynton Beach, FL 33426

    (800) 822-4050

    Rev 09/16

    DRUG FACTS

  • Active Ingredient

    Bisacodyl
    10 mg per suppository.

  • Purpose

    Stimulant
    Laxative

  • Use

    rectally for relief of occasional constipation. This product generally produces a bowel movement within 15 minutes to one hour.

  • Warnings

    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.

    Use of this product

    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.

    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)

    Keep this and all medication 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 – 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)

  • Inactive ingredients

    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 SUPPOSITORIES EACH CONTAINING 10 mg BISACODYL USP Contains No Hydrogenated Vegetable Oil TAMPER RESISTANT: Individually Sealed For Your Protection

  • 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 SUPPOSITORIES EACH CONTAINING 10 mg BISACODYL USP TAMPER RESISTANT: INDIVIDUALLY SEALED FOR YOUR PROTECTION Contains No Hydrogenated Vegetable Oil 10 SUPPOSITORIES Concepts in Confidence

  • INGREDIENTS AND APPEARANCE
    THE MAGIC BULLET 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57648-002
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57648-002-1010 in 1 CARTON; Type 0: Not a Combination Product01/01/2004
    2NDC:57648-002-01100 in 1 CARTON; Type 0: Not a Combination Product01/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2004
    Labeler - Concepts in Confidence (793444902)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549198manufacture(57648-002)
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