NDC 61919-425 Senna

Senna

NDC Product Code 61919-425

NDC Product Information

Senna with NDC 61919-425 is a a human over the counter drug product labeled by Directrx. The generic name of Senna is senna. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Directrx

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Senna Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SENNOSIDES A AND B 8.6 mg/1

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Directrx
Labeler Code: 61919
FDA Application Number: part334 Additional informationCallout TooltipWhat 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat 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.

Start Marketing Date: 03-07-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Senna

Senna is


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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...
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Senna Product Label Images

Senna Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient Section

Sennosides 8.6 mg

Otc - Purpose Section

Laxative-•for relief of occasional constipation and irregularity •this product produces a bowel movement in 6 to 12 hours

Warnings Section

  • Do Not Use
  • Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctorAsk a doctor before use if you have
  • Noticed a sudden change in bowel habits that persists over a period of 2 weeksAsk a Doctor/Pharmacist before use if you are
  • Taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.When Using this product
  • Do not use for longer than 1 week unless directed by a doctorStop Use and ask a doctor
  • Rectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition.If pregnant or breast-feeding
  • Ask a health professional before useKeep Out of Reach of Children
  • In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration Section

  • • Take preferably at bedtime or as directed by doctor • If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortableAgeStarting dosageMaximum dosageAdults and children over 12 years2 tablets once a day4 tablets twice a daychildren 6 to under 12 years1 tablet once a day2 tablets twice a daychildren 2 to under 6 years1/2 tablet once a day1 tablet twice a daychildren under 2 yearsconsult a doctor

Inactive Ingredient Section

Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dehydrate), lactose, magnesium stearate, microcrystalline cellulose, tartaric acid.

Indications & Usage Section

•for relief of occasional constipation and irregularity •this product produces a bowel movement in 6 to 12 hours

Otc - Keep Out Of Reach Of Children Section

KEEP OUT OF REACH OF CHILDREN

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