NDC 71399-8237 Senna

Senna

NDC Product Code 71399-8237

NDC Product Information

Senna with NDC 71399-8237 is a a human over the counter drug product labeled by Akron Pharma Inc.. The generic name of Senna is senna. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Akron Pharma Inc.

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

Product Type: Human Otc Drug 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.

Senna Active Ingredient(s)

What 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 417.12 mg/237mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)

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.
  • 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.

Labeler Name: Akron Pharma Inc.
Labeler Code: 71399
FDA Application Number: part334 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.

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

Start Marketing Date: 10-25-2019 What 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 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

Active Ingredient

Active ingredient (in each 5 ml) purposeSennosides 8.8 mg …………………………................Laxative

Uses

Relieves occasional constipation (irregularity)generally causes bowel movement in 6 to 12 hours

Directions

Shake well before usetake preferably at bedtime or as directed by a doctor

Dosage & Administration

Age                                                                   Starting Dose                           Maximum Doseadults and children                                   12 years 2 - 3 teaspoonfuls         3 teaspoonfuls twice a dayand older once a day6 years to under 12 years of age              1 - 1½ teaspoonfuls once a day       1½ teaspoonfuls twice a day2 to under 6 years of age                       ½ - ¾ teaspoon once a day                 ¾ teaspoon once a dayunder 2 years of age consult a doctor consult a doctor

Warnings

Do Not Use • laxative products for longer than 1 weekunless directed by a doctorAsk a doctor or pharmacist before use if you have• stomach pain • nausea • vomiting• notice a sudden change in bowel movement that continuesover a period of 2 weeksStop use and ask a doctor ifyou have rectal bleeding or failure to have a bowel movementafter use of laxative. These may indicate a serious conditionIf pregnant or breast-feeding, ask a healthprofessional before use

Other Information

  • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Mythylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucrose

Keep Out Of Reach Of Children Section

In case of accidental overdose, get medical help or contact a Poison Control Center immediatelyQuestions?To Report Adverse Drug Event Call 1(877) 225-6999Manufactured for:Akron Pharma Inc.,Fairfield, NJ-07004

* Please review the disclaimer below.