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| Product NDC Code | 71399-8245 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Senna |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||
| RxCUI drug identifier | 312935 | ||||||||
| Application Number | part334 | ||||||||
| Labeler Name | Akron Pharma Inc. | ||||||||
| Packages |
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Overdosage of Senna
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each tablet) 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.Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage Adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day Children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day Children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day Children under 2 years of age ask a doctor ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients microcrystaline cellulose, dicalcium phosphate, sodium starch glycolate, croscarmellose sodium, hypromellose, povidone, collodial silicon dioxide, megnesium stearate.
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) generally causes a bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna Sennosides MICROCRYSTALLINE CELLULOSE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM STARCH GLYCOLATE TYPE A CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED POVIDONE SILICON DIOXIDE MAGNESIUM STEARATE SENNOSIDES SENNOSIDES AP45
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.UD 8.6
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.Tamper Evident: Do not use if imprinted inner safety seal is torn or missing. This product is not manufactured or distributed by Purdue Products L.P., Owner of the registered trademark Senokot ® Manufactured for: Akron Pharma Inc Fairfield, NJ 07004 www.akronpharma.com
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 stomach pain nausea vomiting noticed a sudden change in bowel habits that continues 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 laxative products for longer than one week unless directed by a doctor
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Each tablet contains: Calcium 14 mg Store between 15º to 30ºC (59 to 86F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-(877) 255-6999
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 of a laxative. These may indicate a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care 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 laxative products for longer than one week unless directed by a doctor Do not use laxative products for longer than one week unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact 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