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| Product NDC Code | 71610-058 | ||||
|---|---|---|---|---|---|
| Drug Name | Senexon |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, COATED | ||||
| RxCUI drug identifier | 312935, 404182 |
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| Application Number | part334 | ||||
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC | ||||
| 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) Sennosides 8.6mg
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.Dosage and Administration Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol 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.Relieves occasional constipation Generally produces bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.uses relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.
Spl product data elements
Usually a list of ingredients in a drug product.SENEXON SENNA SENNOSIDES A and B SENNOSIDES A and B CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE 2910 (6 MPA.S) magnesium stearate CELLULOSE, MICROCRYSTALLINE mineral oil TCL080
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 - 8.6 mg NDC 71610-058 - Sennosides (Senna) 8.6 mg Bottle Label 8.6 mg
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.Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 8.6 mg 100 71610-058-65 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20180514JH Aphena Pharma Solutions - TN
| Count | |
| 100 | 71610-058-65 |
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 noticed a sudden change in bowel habits that lasts over two weeks.
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 a doctor or pharmacist before use if you are taking any other drug. Take this product tow or more hours before or after other drugs. Laxatives may affect how other drugs work.
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.1800 645-2158 9 am - 5 pm Monday - Friday
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; you fail to have a bowel movement after use of this product. These may indicate a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.
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