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| Product NDC Code | 49483-003 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 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 | ORAL | ||||||||||
| Dosage Form | TABLET, DELAYED RELEASE | ||||||||||
| RxCUI drug identifier | 308753 | ||||||||||
| Application Number | part334 | ||||||||||
| Labeler Name | TIME CAP LABORATORIES, 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.In each tablet: Bisacodyl 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.adults and children 12 years and over: take 1 to 3 tablets in a single daily dose children 6 to under 12 years: take 1 tablet in a single daily dose children under 6 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide
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: relieves occasional constipation and irregularity this product generally produces a bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Stimulant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.STIMULANT LAXATIVE BISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE POVIDONE SHELLAC SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE BISACODYL DEACETYLBISACODYL TCL003
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.25 COUNT BLISTER image description
100 count label 14R 14R 100CT LABEL
1000 CT 14R 14R 1000 CT LABEL
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: In case of overdose, get medical help or contact a Poison Control Center right away.
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: Do not use if you cannot swallow without chewing. Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks. When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.
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