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| Product NDC Code | 57237-327 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | part334 | ||||||
| Labeler Name | Rising Pharma Holdings, Inc. | ||||||
| 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 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 adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes children 6 to under 12 years 1/2 suppository in a single daily dose children under 6 years Do not use
| children 6 to under 12 years | 1/2 suppository in a single daily dose |
| children under 6 years | Do not use |
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.Use for relief of occasional constipation (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.Bisacodyl Bisacodyl BISACODYL DEACETYLBISACODYL FAT, HARD
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.NDC 57237-327-21 (3 blisters of 4 suppositories) Bisacodyl USP Suppositories 10 mg Stimulant Laxative Gentle, Predictable, Fast Relief DO NOT SWALLOW NDC 57237-327-04 (4 suppositories in 1 blister pack) Front Foil Back Foil Bisc-supp-01 Bisc-supp-02 Bisc-supp-03
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: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India CODE NO.: MH/DRUGS/25-KD/724 Issued: 08/2023
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 stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks
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.TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING
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? Call 1-844-474-7464
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 need to use a laxative product for longer than one week you have rectal bleeding or no bowel movement after using this product. These could be signs of 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 experience stomach discomfort, faintness, rectal burning and mild cramps
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25°C (68-77°F) if suppository softens prior to use, may be placed in refrigerator for short time
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