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| Product NDC Code | 58980-415 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Stratuscare bisacodyl |
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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 | part334 | ||||||||
| Labeler Name | Stratus Pharmaceuticals | ||||||||
| 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 (in each suppository) Bisacodyl 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 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 a doctor Detach one suppository from the strip and remove from foil Carefully insert well into rectum Do not use more than once per day
| 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 a doctor |
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.Uses for 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 Stimulative laxative
Spl product data elements
Usually a list of ingredients in a drug product.Stratuscare Bisacodyl Bisacodyl Bisacodyl DEACETYLBISACODYL HYDROGENATED SOYBEAN 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.PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box STRATUSCARE 12 Suppositories Comfort Shaped Distributed by: STRATUS PHARMACEUTICALS INC NDC 58980-415-12 Gentle Laxative (BISACODYL USP 10 mg) Stimulant laxative Gentle yet effective WORKS IN 15 MINUTES TO 1 HOUR Compare to the active ingredient in Dulcolax ® * PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box
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
Distributed by: Stratus Pharmaceuticals Inc 12379 SW 130th Street Miami, Florida 33186
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 persist 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 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. 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? 1-800-442-7881
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 use of a laxative because 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 you may have abdominal 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 15°C to 30°C (59°F to 86°F). Do not exceed 30°C (86°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.Warning for rectal use only 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 Ask a doctor before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks When using this product you may have abdominal 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 use of a laxative because this 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