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| Product NDC Code | 81440-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Bisac-10 bisacodyl stimulant 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 | part334 | ||||
| Labeler Name | GALEN PHARMACEUTICALS LIMITED | ||||
| 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 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: 1 suppository, once daily • suppository should be moistened with water before inserting.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients polyethylene glycol
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 • this product generally produces bowel movement in 1/4 to 1 hour
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.BISAC-10 Bisacodyl Stimulant Laxative Bisacodyl BISACODYL DEACETYLBISACODYL POLYETHYLENE GLYCOL, UNSPECIFIED Cylindrical
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.Packaging IMAGE
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
Bisacodyl Stimulant Laxative Suppositories For Adults FOR RECTAL USE ONLY Manufactured by: Galen Pharmaceuticals Ltd. 334/5 GIDC Estate Waghodia, Vadodara, Gujarat, India, 391760 Country of Origin: India Web: www.galenltd.com
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? +1-863-434-1782 You may also report serious side effects to this phone number. Mon - Sun: 24/7
Storage and handling
Information about safe storage and handling of the drug product.Other information • store in well closed containers
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 • laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor • laxative products for a period longer than 1 week unless directed by a doctor Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks When using this product it may cause • abdominal discomfort • faintness • rectal burning • mild cramps • store at temperatures not above 86°F (30°C) Stop use and ask a doctor if • rectal bleeding • failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition. 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