NDC 66424-378 Senna Plus

Sennosides 8.6mg And Docusate Sodium 50mg

NDC Product Code 66424-378

NDC Code: 66424-378

Proprietary Name: Senna Plus 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.

Non-Proprietary Name: Sennosides 8.6mg And Docusate Sodium 50mg 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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
PH32
Score: 1

NDC Code Structure

  • 66424 - Sda Laboratories, Inc.
    • 66424-378 - Senna Plus

NDC 66424-378-02

Package Description: 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Senna Plus with NDC 66424-378 is a a human over the counter drug product labeled by Sda Laboratories, Inc.. The generic name of Senna Plus is sennosides 8.6mg and docusate sodium 50mg. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Sda Laboratories, Inc.

Dosage Form: Tablet, 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.

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 Plus 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 8.6 mg/1
  • DOCUSATE SODIUM 50 mg/1

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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Sda Laboratories, Inc.
Labeler Code: 66424
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: 04-15-2019 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 Plus 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 Ingredients (In Each Tablet)

Sennosides from Senna Concentrate 8.6mgDocusate Sodium 50mg

Purpose

LaxativeStool softner

Uses

  • Relieves occasional constipation (irregularity)generally produces a bowel movement in 6-12 hours

Warnings

  • Do not uselaxative products for longer than 1 week unless directed by a doctorif you are taking mineral oil, unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Stomach painnauseavomitingnoticed 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 the use of a laxative. These may indicate a serious condition.

If Pregnant Or Breast Feeding,

Ask a healthcare professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Take preferably at bedtime or as directed by a doctoragestarting dosagemaximum dosageAdults and children 12 years and over2 tablets once a day 4 tablets twice a dayChildren 6 to under 12 years1 tablet once a day2 tablets  twice a dayChildren 2 to under 6 years 1/2 tablet  once a day1 tablet twice a dayChildren under 2 yearsask a doctorask a  doctor

Other Information

  • Each tablet contains 10 mg of calcium, sodium 5 mgstore at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive Ingredients

Croscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

* Please review the disclaimer below.

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