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| Product NDC Code | 57648-002 | ||||||
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| Drug Name | The magic bullet |
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| Type | Brand | ||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | RECTAL | ||||||
| Dosage Form | SUPPOSITORY | ||||||
| RxCUI drug identifier | 198509, 284283 |
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| Application Number | part334 | ||||||
| Labeler Name | Concepts in Confidence | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Bisacodyl 10 mg per suppository.
Active Ingredient Bisacodyl 10 mg per suppository.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Polyethylene glycol, propylene glycol diacetate. Mfg. for Concepts in Confidence Boynton Beach, FL 33426 (800) 822-4050 Rev 09/16 DRUG FACTS
Inactive ingredients Polyethylene glycol, propylene glycol diacetate. Mfg. for Concepts in Confidence Boynton Beach, FL 33426 (800) 822-4050 Rev 05/14
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use rectally for relief of occasional constipation. This product generally produces a bowel movement within 15 minutes to one hour.
Use rectally for relief of occasional constipation. This product generally produces a bowel movement within 15 minutes to one hour.
Purpose
Information about the drug product’s indications for use.Purpose Stimulant Laxative
Purpose Stimulant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.The Magic Bullet Bisacodyl BISACODYL DEACETYLBISACODYL POLYETHYLENE GLYCOL 1450 POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL DIACETATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Other information Store below 86°F (30°C)
Other information Store below 86°F (30°C)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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)
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)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep this and all medication out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep this and all medication out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API