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Senna - Medication Information

Product NDC Code 68016-745
Drug Name

Senna

Type Brand
Active Ingredients
Sennosides 8.6 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 312935
Application Number 505G(a)(3)
Labeler Name CHAIN DRUG CONSORTIUM, LLC
Packages
Package NDC Code Description
68016-745-00 1 bottle in 1 carton (68016-745-00) / 100 tablet in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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 do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor
AgeStarting DoseMaximum Dose
adults and children 12 years of age and older2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor4 tablets in the morning and 4 tablets at bedtime
children under 12 yearsask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose*, magnesium silicate*, magnesium stearate, mineral oil*, PEG*, silica*, wax*. *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 this product generally produces a bowel movement in 6 to 12 hours relieves occasional constipation (irregularity)

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 SILICON DIOXIDE CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM SILICATE MAGNESIUM STEARATE MINERAL OIL HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED SENNOSIDES SENNOSIDES AZ217

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 label 451

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information each tablet contains: calcium 40 mg store at room temperature 15-30C (59-86F)

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 for more than one week unless directed by a doctor. Ask a doctor before use if you have abdominal pain, nausea or vomiting have noticed a sudden change in bowel habits that lasts over two weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use if a laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health 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