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| Product NDC Code | 45865-913 | ||||
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| Drug Name | Senna/docusate sodium |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED | ||||
| RxCUI drug identifier | 998740 | ||||
| Application Number | part334 | ||||
| Labeler Name | medsource pharmaceuticals | ||||
| 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 Ingredients (in each tablet) Docusate Sodium 50 mg Sennosides 8.6 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.Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided dose. Age Dosage Adults and children 12 years of age and older Take 2-4 tablets daily Children 6 to under 12 years Take 1-2 tablets daily Children 2 to 6 years Take up to 1 tablet daily Children under 2 years Do not use
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch*, tartaric acie*, and titanium dioxide. *may contain these ingredients.
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 (irregularity). This product generally produces a bowel movement in 6 to 12 hours.
Purpose
Information about the drug product’s indications for use.Purpose Stool Softener Stimulant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna/Docusate Sodium Docusate sodium and Sennosides CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 SODIUM BENZOATE STEARIC ACID TITANIUM DIOXIDE SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE TCL097
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.pdp
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.Generic Section Other information Each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM Each tablet contains: calcium 20 mg/tablet. Store at 20° - 25°C (68° -77°F); excursions permitted to 15°-30° (59°-86°F). [See USP Controlled Room Temperature]
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask Doctor/Pharmacist Ask a doctor or pharmacist before use if you are presently taking mineral oil.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Questions? To Report Serious Adverse Effects Call: (800)616-2471 Distributed By: Major® Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA LHC51790417
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 Ask a doctor before use if you have Stomach pain Nausea Vomiting A sudden change in bowel habits that lasts over a period of 2 weeks. DO NOT USE Laxative products for longer than 1 week unless directed by a doctor If you are presently taking mineral oil, unless directed by 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