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Product NDC Code | 69842-816 | ||||||||
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Drug Name | Bisacodyl |
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Type | Generic | ||||||||
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 | ||||||||
Application Number | M007 | ||||||||
Labeler Name | CVS Pharmacy | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each suppository) Bisacodyl USP 10mg
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 detach one suppository from the strip remove wrapper berore inserting into rectum adults and children 12 years of age and over - 1 suppository once daily children 6 to under 12 years of age - 1/2 suppository once daily children under 6 years of age - do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients hydrogenated vegetable oil
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 for temporary relief of occasional constipation this product generally produces bowel movement in 15 minutes to 1 hour
Purpose
Information about the drug product’s indications for use.Purpose Stimulant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Bisacodyl Bisacodyl BISACODYL DEACETYLBISACODYL HYDROGENATED PALM KERNEL OIL
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.CVS Bisacodyl Suppositories CVSBisacodyl8ct.jpg The product package shown above represents a sample of that currently in use. Additional packaging may also be available. Bisacodyl Suppositories 8ct Distributed by CVS Pharmacy One CVS Drive Woonsocket, RI 02895 CVS Bisacodyl 8ct
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 you have noticed a sudden change in bowel habits that last over a period 2 weeks
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 unless directed by a doctor if abdominal pain, nausea or vomiting are present for longer than 1 week
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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temeratur. Do not exceed 30ºC (86ºF) Lot No. & Exp. Date: see wrapper or box
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 you have rectal bleeding or fail to have a bowel movement after using this product. These may indicate a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health professional before use.
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 For rectal use only Do not use unless directed by a doctor if abdominal pain, nausea or vomiting are present for longer than 1 week Ask a doctor before use if you have noticed a sudden change in bowel habits that last over a period 2 weeks When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These may indicate a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of 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