Senna
Sennosides 8.6 Mg Tablets
Aace Pharmaceuticals, Inc.
Human Otc Drug
NDC 71406-105Senna also known as Sennosides 8.6 Mg Tablets is a human otc drug labeled by 'Aace Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Senna is 71406-105. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Senna drug includes Sennosides - 8.6 mg/1 . The currest status of Senna drug is Active.
Drug Information:
| Drug NDC: | 71406-105 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Senna |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sennosides 8.6 Mg Tablets |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aace Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SENNOSIDES - 8.6 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 30 Aug, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | AACE PHARMACEUTICALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312935
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0371406105010
0371406105102
|
| UPC stands for Universal Product Code. |
| UNII: | 3FYP5M0IJX
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71406-105-01 | 100 TABLET in 1 BOTTLE, PLASTIC (71406-105-01) | 30 Aug, 2019 | N/A | No |
| 71406-105-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (71406-105-10) | 30 Aug, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose laxative
Product Elements:
Senna sennosides 8.6 mg tablets sennosides sennosides croscarmellose sodium silicon dioxide hypromellose 2910 (5 mpa.s) magnesium stearate stearic acid microcrystalline cellulose light brown to grey s5
Indications and Usage:
Uses relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours
Warnings:
Warnings do not use laxative products for longer than 1 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 professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use laxative products for longer than 1 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 professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a docto
Stop Use:
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.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in senokot® senna tablets sennosides 8.6 mg natural vegetable laxative gentle, overnight relief of constipation tamper evident: do not use if imprinted safety seal under cap is broken or missing manufactured by: aace pharmaceuticals, inc. fairfield, nj 07004 aacepharma.com this product is not manufactured or distributed by purdue products l.p., owner of the registered trademark senokot®. ndc 71406-105-01 ndc 71406-105-10