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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
-
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.
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.
- Directions
- Other information
- Inactive ingredients
- Active Ingredient
- Purpose
- Use
-
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.
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.
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL – 100 Suppositories
- PRINCIPAL DISPLAY PANEL – 10 Suppositories
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INGREDIENTS AND APPEARANCE
THE MAGIC BULLET
bisacodyl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57648-002 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 10 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57648-002-10 10 in 1 CARTON; Type 0: Not a Combination Product 01/01/2004 2 NDC:57648-002-01 100 in 1 CARTON; Type 0: Not a Combination Product 01/01/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2004 Labeler - Concepts in Confidence (793444902) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(57648-002)