NDC 0904-6725 Sennosides
Tablet, Film Coated Oral

Product Information

Sennosides is a human over the counter drug product labeled by Major Pharmaceuticals. The product's dosage form is tablet, film coated and is administered via oral form.

Product Code0904-6725
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Sennosides
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Sennosides
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Major Pharmaceuticals
Labeler Code0904
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part334
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-20-2018
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Sennosides?


Product Packages

NDC 0904-6725-59

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.02144 per EA

NDC 0904-6725-80

Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.02144 per EA

Product Details

What are Sennosides Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SENNOSIDES 8.6 mg/1 - Medications derived from SENNA EXTRACT that are used to treat CONSTIPATION.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Senna

Senna is


...
[Read More]
Senna

Senna is pronounced as (sen' a)
Why is senna medication prescribed?
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medic...
[Read More]

* Please review the disclaimer below.

Sennosides Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6 mg


Purpose



Laxative


Uses



  • relieves occasional constipation (irregularity)
  • generally causes a bowel movement in 6-12 hours

Warnings



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.


Directions



  • take preferably at bedtime or as directed by a doctor
    • Adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
    • Children 6 to under 12 yearsof age: 1 tablet once a day: maximum 2 tablets once a day
    • Children 2 to under 6 yearsof age ½ tablet once a day: maximum 1 tablet once a day
    • Children under 2 years of age: ask a doctor

Inactive Ingredients



croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil and polyethylene glycol


Other



Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Product color may slightly vary

due to natural changes of ingredients.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

M-29 Rev. 04/17 Re-Order No. 700532


Package Label.Principal Display Panel



NDC 0904-6522-61

MAJOR® PHARMACEUTICALS

Unit Dose

SENNA-LAX

(Standardized Senna Concentrate)

8.6 mg Sennosides

100 TABLETS


* Please review the disclaimer below.