NDC 0113-1023 Good Sense Clearlax
Polyethylene Glycol 3350 Powder, For Solution Oral

Product Information

What is NDC 0113-1023?

The NDC code 0113-1023 is assigned by the FDA to the product Good Sense Clearlax which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Clearlax is polyethylene glycol 3350. The product's dosage form is powder, for solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-1023-03 510 g in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0113-1023
Proprietary Name 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.
Good Sense Clearlax
Non-Proprietary Name 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.
Polyethylene Glycol 3350
Product Type 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.
Human Otc Drug
Dosage FormPowder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
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.
L. Perrigo Company
Labeler Code0113
FDA Application Number 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.
ANDA090685
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-27-2022
Listing Expiration Date 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.
12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Good Sense Clearlax?


Product Characteristics

Color(s)WHITE (C48325)
Flavor(s)ORANGE (C73406)

Product Packages

NDC Code 0113-1023-03

Package Description: 510 g in 1 BOTTLE

Product Details

What are Good Sense Clearlax Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Good Sense Clearlax Active Ingredients UNII Codes

  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 876193 - polyethylene glycol 3350 17 GM Powder for Oral Solution
  • RxCUI: 876193 - polyethylene glycol 3350 17000 MG Powder for Oral Solution

Good Sense Clearlax Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Good Sense Clearlax Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Dose)



Polyethylene Glycol 3350, 17 g (cap filled to line)


Purpose



Osmotic Laxative


Use



  • •relieves occasional constipation (irregularity)
  • •generally produces a bowel movement in 1 to 3 days

Warnings



Allergy alert: Do not use if you are allergic to polyethylene glycol


Do Not Use



if you have kidney disease, except under the advice and supervision of a doctor


Ask A Doctor Before Use If You Have



  • •nausea, vomiting or abdominal pain
  • •a sudden change in bowel habits that lasts over 2 weeks
  • •irritable bowel syndrome

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug


When Using This Product



you may have loose, watery, more frequent stools


Stop Use And Ask A Doctor If



  • •you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
  • •you get diarrhea
  • •you need to use a laxative for longer than 1 week

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 (1-800-222-1222).


Directions



  • do not take more than directed unless advised by your doctor
  • •the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
  • •adults and children 17 years of age and older:
  • •use once a day
  • •fill to top of white section in cap which is marked to indicate the correct dose (17 g)
  • •stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • •do not combine with starch-based thickeners used for difficulty swallowing
  • •ensure that the powder is fully dissolved before drinking
  • •do not drink if there are any clumps
  • •do not use more than 7 days
  • •children 16 years of age or under: ask a doctor

Other Information



  • •store at 20°-25°C (68°-77°F)
  • •tamper -evident: do not use if printed foil seal under cap is missing, open or broken

Inactive Ingredients



natural and artificial orange flavor, sucralose


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



GOOD SENSE®

Grit Free Powder

ClearLax®

Polyethylene Glycol 3350 Powder for Solution

Osmotic Laxative

Sugar-Free

Dye-Free

• Relieves Occasional Constipation/Irregularity

• Softens Stool

Compare to active ingredient of MiraLAX®

Orange Flavor

NET WT 17.9 OZ (510 g) 30 Once-Daily Doses


* Please review the disclaimer below.