NDC 41163-815 Laxative Maximum Strength

Sennosides

NDC Product Code 41163-815

NDC Code: 41163-815

Proprietary Name: Laxative Maximum Strength 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):
11 MM
Imprint(s):
TCL083
Score: 1

Code Structure
  • 41163 - Equaline (supervalu)
    • 41163-815 - Laxative

NDC 41163-815-24

Package Description: 24 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK

NDC 41163-815-48

Package Description: 48 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK

NDC Product Information

Laxative Maximum Strength with NDC 41163-815 is a a human over the counter drug product labeled by Equaline (supervalu). The generic name of Laxative Maximum Strength is sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Equaline (supervalu)

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.


Laxative Maximum Strength 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.

  • ACACIA (UNII: 5C5403N26O)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)

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: Equaline (supervalu)
Labeler Code: 41163
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.

Laxative Maximum Strength Product Label Images

Laxative Maximum Strength 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 USP, 25 mg

Purpose

Stimulant laxative

Uses

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

Do Not Use

Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • Noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You

  • Are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When Using This Product

  • Do not use for a period longer than 1 week

Stop Use And Ask A Doctor If

  • Rectal bleeding or failure to have a bowel movement occur after use of a laxativeThese may be signs of 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 Posion Control Center right away.

Directions

  • Swallow tablet(s) with a glass of waterswallow tablet(s) whole, do not crush, break, or chewadults and children 12 years of age and oldertake 2 tablets once or twice daily children 6 to under 12 years of agetake 1 tablet once or twice dailychildren under 6 years of age ask a doctor

Other Information

  • Each tablet contains: calcium 40 mgvery low sodium
  • Store between 20-25ºC (68-77ºF)

Inactive Ingredients

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

Product Label

EQUALINE Maximum Strength Laxative

* Please review the disclaimer below.

Previous Code
41163-810
Next Code
41163-816