NDC 11673-995 Maximum Strength Laxative Pills

Sennosides

NDC Product Code 11673-995

NDC Code: 11673-995

Proprietary Name: Maximum Strength Laxative Pills 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):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
TCL083
Score: 1

NDC Code Structure

  • 11673 - Target Corporation
    • 11673-995 - Maximum Strength Laxative Pills

NDC 11673-995-48

Package Description: 48 TABLET in 1 BLISTER PACK

NDC Product Information

Maximum Strength Laxative Pills with NDC 11673-995 is a a human over the counter drug product labeled by Target Corporation. The generic name of Maximum Strength Laxative Pills is sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Target Corporation

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.

Maximum Strength Laxative Pills 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 25 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.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • RAW SUGAR (UNII: 8M707QY5GH)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POVIDONE (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • CALCIUM CATION (UNII: 2M83C4R6ZB)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • TALC (UNII: 7SEV7J4R1U)
  • ACACIA (UNII: 5C5403N26O)

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: Target Corporation
Labeler Code: 11673
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: 04-09-2019 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.

Information for Patients

Senna

Senna is pronounced as (sen' a)

Why is senna medication prescribed?
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medic...
[Read More]
Senna

Senna is

...
[Read More]

* Please review the disclaimer below.

Maximum Strength Laxative Pills Product Label Images

Maximum Strength Laxative Pills 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

Each Tablet contains:CALCIUM SENNOSIDES 25 mg

Inactive Ingredients

Acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide

Purpose

Stool softener, laxative

Dosage & Administration

Directions: Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a dayChildren 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a dayChildren 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a dayChildren under 2 years - Ask a doctor

Indications & Usage

Uses: Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours
CLOSE

Warnings

WARNINGS:Do not use this product

If you are presently taking mineral oil unless directed by a doctor

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

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.

* Please review the disclaimer below.

Previous Code
11673-986
Next Code
11673-996