NDC 37808-731 Senna Laxative

Sennosides

NDC Product Code 37808-731

NDC Code: 37808-731

Proprietary Name: Senna Laxative 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 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):
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
TCL080;PS;S8
Score: 1

NDC Code Structure

  • 37808 - H E B
    • 37808-731 - Senna Laxative

NDC 37808-731-01

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 100 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Senna Laxative with NDC 37808-731 is a a human over the counter drug product labeled by H E B. The generic name of Senna Laxative is sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: H E B

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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 Laxative 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

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.

  • TRIACETIN (UNII: XHX3C3X673)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)

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: H E B
Labeler Code: 37808
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: 02-28-2019 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 Laxative Product Label Images

Senna Laxative 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 (In Each Tablet)

Sennosides 8.6 mg

Purpose

Stimulant Laxative

Uses

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

Do Not Use

  • Laxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Using 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.

Directions

  • Take preferably at bedtime or as directed by a doctoragestarting dosage maximum dosage  adults and children 12 years of age and over 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 tablets once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Other Information

  • Each tablet contains: calcium 30 mgstore at 25oC (77o F); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

Croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose*, magnesium stearate,  microcrystalline cellulose, mineral oil*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*, triacetin**contains one or more of these ingredients

Product Label

H-E-B Senna Laxative

* Please review the disclaimer below.

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