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| Product NDC Code | 69168-398 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bisacodyl 5mg |
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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 | ORAL | ||||||
| Dosage Form | TABLET, COATED | ||||||
| RxCUI drug identifier | 308753 | ||||||
| Application Number | M007 | ||||||
| Labeler Name | Allegiant Health | ||||||
| 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 tablet) Bisacodyl USP 5mg
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 take with water Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily Children 6 to 12 years of age: take 1 tablet once a day Children under 6 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl acetate pthalate, polydextrose, polyethylene glycol, propylparaben, propylene glycol, povidone, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
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 (irregularity) this product generally produces bowel movement in 6 to 12 hours
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 5mg Bisacodyl 5mg BISACODYL DEACETYLBISACODYL ACACIA CALCIUM CARBONATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C RED NO. 27 FD&C BLUE NO. 2--ALUMINUM LAKE FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE METHYLPARABEN Polyvinyl Acetate Phthalate POLYDEXTROSE POLYETHYLENE GLYCOL 1000 PROPYLPARABEN PROPYLENE GLYCOL POVIDONE SHELLAC SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE
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 Bisacodyl 5mg Pink Bisacodyl 5mg Pink
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.Other information store between 68º to 77ºF (20º to 25ºC) do not use blister unit is broken or torn
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 abdominal pain nausea vomiting noticed a sudden change in bowel habits that persists over a period of 2 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 if you are unable to swallow without chewing within 1 hour after taking an antacid or milk
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. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) 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 if you need to use more than 1 week rectal bleeding or failure to have a bowel movement after use of a laxative. These may 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 do not chew or crush tablets abdominal discomfort, faintness, and cramps may occur
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant 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 Do not use if you are unable to swallow without chewing within 1 hour after taking an antacid or milk Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks When using this product do not chew or crush tablets abdominal discomfort, faintness, and cramps may occur Stop use and ask a doctor if you need to use more than 1 week rectal bleeding or failure to have a bowel movement after use of a laxative. These may be signs of a serious condition. If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) 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