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Product NDC Code | 76457-003 | ||||
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Drug Name | Simpex bisacodyl 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, COATED | ||||
RxCUI drug identifier | 308753 | ||||
Application Number | M007 | ||||
Labeler Name | Simpex Pharma Pvt. Ltd | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Bisacodyl 5 mg Purpose Stimulant Laxative
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 a glass of water. Adults and children 12 years and over take 1 to 3 tablets in a single daily dose Children 6 to under 12 years of age take 1 tablet in a single daily dose Children under 6 years ask a doctor
Adults and children 12 years and over | take 1 to 3 tablets in a single daily dose |
Children 6 to under 12 years of age | 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.Inactive ingredients anhydrous lactose, colloidal anhydrous silica, hypermellose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, povidone, sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type A, talc, titanium dioxide,triethyle 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 relives occasional constipation and 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.SIMPEX Bisacodyl laxative BISACODYL ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSE 2208 (15000 MPA.S) FERRIC OXIDE RED FERRIC OXIDE YELLOW POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 600 POVIDONE SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE BISACODYL DEACETYLBISACODYL Clear BiConvex ;
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.Package Labeling: Label3
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
Other information preserve in well-closed containers at a temperature not exceeding 30°C avoid excessive humidity
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 can not 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 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. In case or overdose, get medical help orcontact a poison control center 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 have rectal bleeding or fail to have a bowel movement after use a laxative. these could be signs of a serious condition. you need to use a laxative for more than 1 week if pregnant or breast-feeding, ask a health professional before use.
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 tablet (s) do not use within 1 hour after taking an antacid or milk you may have stomach discomfort, faintness or cramps
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 can not 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 weeks When using this product do not chew or crush tablet (s) do not use within 1 hour after taking an antacid or milk you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use a laxative. these could be signs of a serious condition. you need to use a laxative for more than 1 week if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. In case or overdose, get medical help orcontact 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