NDC 81033-001 Senna

Sennosides

NDC Product Code 81033-001

NDC 81033-001-41

Package Description: 8 BOX in 1 CASE > 40 CUP in 1 BOX (81033-001-40) > 10 mL in 1 CUP (81033-001-10)

NDC 81033-001-43

Package Description: 8 BOX in 1 CASE > 40 CUP in 1 BOX (81033-001-42) > 15 mL in 1 CUP (81033-001-15)

NDC 81033-001-51

Package Description: 8 BOX in 1 CASE > 50 CUP in 1 BOX (81033-001-50) > 5 mL in 1 CUP (81033-001-05)

NDC Product Information

Senna with NDC 81033-001 is a a human over the counter drug product labeled by Kesin Pharma Corporation. The generic name of Senna is sennosides. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Kesin Pharma Corporation

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 8.8 mg/5mL

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)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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.

Labeler Name: Kesin Pharma Corporation
Labeler Code: 81033
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: 03-10-2021 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: 12-31-2022 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 - NO 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 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

Active ingredient (in each 5mL teaspoonful)Sennosides 8.8mg

Otc - Purpose

Laxative

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of a laxative.These may indicate a serious condition.

Otc - Keep Out Of Reach Of Children

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Ask Doctor/Pharmacist

  • Ask a doctor before use if you have stomach pain, nausea or vomittingNoticed a change in bowel habits over two weeks

Warnings

Do not use laxative products for longer than one week unless directed by a doctor

Otc - Questions

Questions or Comments? 833-537-4679

Dosage & Administration

AgeStarting DoseMaximum DoseAdults and children 12 years and older2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoonfuls in the morning and 3 teaspoonfuls at bedtimeUnder 12 years of ageAsk a doctorAsk a doctor

Inactive Ingredient

Artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Storage And Handling

Store at room temperature (59-77 degrees F)

Indications & Usage

  • UsesRelieves ocassional constipation (irregularity)Generally causes bowel movement in 6 to 12 hours

* Please review the disclaimer below.