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Product NDC Code | 57896-443 | ||||||||
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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 | GERI-CARE PHARMACEUTICAL CORP | ||||||||
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, 10 mg
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 tear off one suppository from the strip peel apart the wrapper continue peeling apart to almost the full length of the suppository (see illustration at the right) gently remove the suppository from the wrapper lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out retain it for about 15 to 20 minutes. Do not exceed recommended dose if suppository seems soft, place in refrigerator for a short time before use adults and children 12 years and over 1 suppository once daily children under 12 years Ask a doctor
children under 12 years | Ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient hard fat
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.Uses relieves occasional constipation this product generally produces a 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 FAT, HARD BISACODYL DEACETYLBISACODYL
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.1
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
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 a sudden change in bowel habits that lasts 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 when abdominal pain, nausea, or vomiting are present.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-800-540-3765
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 you fail to have bowel movement after using a laxative. These may be signs of a serious condition. you need to use a laxative product for more than one week
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 you may experience rectal burning mild cramps abdominal discomfort faintness
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at temperatures below 25 C (77F) Made in India
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 when abdominal pain, nausea, or vomiting are present.
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