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Product NDC Code | 43749-460 | ||||
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Drug Name | Avedana gentle laxative |
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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 | ||||
Application Number | M007 | ||||
Labeler Name | Unipack LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each Suppository) Purpose Bisacodyl USP, 10 mg.................................Stimulant Laxative
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 Adults and children 12 years of age and older Children 6 to under 12 years Children under 6 One suppository once daily 1/2 suppository once daily Ask doctor. -Detach one suppository from the strip and remove from foil - Carefully insert one suppository well into the rectum -Do not use more than once per day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Inactive ingredient 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.Uses Uses - For temporarily relief of occasional constipation and irregularity -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.Avedana Gentle Laxative Bisacodyl PALM KERNEL OIL 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.Label Avedana ® Bisacodyl Suppositories Product Label
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 Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two 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 Do not use - more than once per day - for a period of longer than one week unless directed by a doctor - laxative products when abdominal pain, nausea, or vomiting are present 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 out of reach of children Keep out of 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 Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative. This 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 When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding If 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 Other information - Store at room temperature: 15 o - 30 o C (59 o - 86 o F). Do not exceed 30 o C (86 o F) - Individually sealed for your protection. Do not use if foil is torn or open
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.
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