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Bisacodyl - Medication Information

Product NDC Code 0904-7142
Drug Name

Bisacodyl

Type Generic
Pharm Class Increased Large Intestinal Motility [PE],
Stimulant Laxative [EPC],
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Active Ingredients
Bisacodyl 10 mg/1
Route RECTAL
Dosage Form SUPPOSITORY
RxCUI drug identifier 198509
Application Number M007
Labeler Name Major Pharmaceuticals
Packages
Package NDC Code Description
0904-7142-12 2 blister pack in 1 carton (0904-7142-12) / 6 suppository in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each suppository) Bisacodyl USP, 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 over - One suppository once daily Children 6 to under 12 years of age - 1/2 suppository once daily Children under 6 - Ask a doctor Detach one suppository from the strip and remove the foil Carefully insert one suppository well into the rectum, pointed end first Do not use more than once per day Retain about 15 to 20 minutes

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 temporary 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.
Bisacodyl Bisacodyl HYDROGENATED 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.
Major Bisacodyl Suppositories Major_Bisacodyl_12.jpg The product package shown above represents a sample of that currently in use. Additional packaging may also be available. Bisacodyl Suppositories 12ct Distributed by Major Pharmaceuticals Livonia, MI 48152 Major Bisacodyl 12

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 using any laxative if you have notice 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 (1-800-222-1222) right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Storage temperature not to exceed 30ºC (86ºF) Indiviually sealed for your protection. Do not use if foil is torn or open.

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? (800) 616-2471

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 using a laxative. These 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 may cause stomach discomfort, faintness, rectal burning and mild cramps

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast feeding, ask a health professional before use.

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 more than once per day for a period longer than one week unless directed by a doctor laxative products when abdominal pain, nausia, or vomiting are present unless directed a doctor Ask a Doctor before using any laxative if you have notice a sudden change in bowel habits that lasts more than 2 weeks When using this product may cause stomach 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 using a laxative. These 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 (1-800-222-1222) right away. Do not use more than once per day for a period longer than one week unless directed by a doctor laxative products when abdominal pain, nausia, or vomiting are present unless directed a doctor

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