NDC 36800-306 Topcare Clearlax

Polyethylene Glycol 3350

  1. Labeler Index
  2. Topco Associates Llc
  3. NDC: 36800-306 Topcare Clearlax

NDC Product Code 36800-306

NDC CODE: 36800-306

Proprietary Name: Topcare Clearlax 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: Polyethylene Glycol 3350 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

NDC Code Structure

NDC 36800-306-01

Package Description: 119 g in 1 BOTTLE

NDC 36800-306-02

Package Description: 238 g in 1 BOTTLE

NDC 36800-306-03

Package Description: 507 g in 1 BOTTLE

NDC 36800-306-07

Package Description: 3 BOTTLE in 1 PACKAGE > 510 g in 1 BOTTLE

NDC 36800-306-19

Package Description: 595 g in 1 BOTTLE

NDC 36800-306-20

Package Description: 2 BOTTLE in 1 PACKAGE > 850 g in 1 BOTTLE

NDC Product Information

Topcare Clearlax with NDC 36800-306 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Clearlax is polyethylene glycol 3350. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

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.

Topcare Clearlax 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.
  • POLYETHYLENE GLYCOL 3350 17 g/17g

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: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: ANDA090685 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 10-07-2009 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: 12-31-2021 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’.

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Information for Patients

Polyethylene Glycol 3350

Polyethylene Glycol 3350 is pronounced as (pol ee eth' i leen) (glye' col)

Why is polyethylene glycol 3350 medication prescribed?
Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing wat...
[Read More]

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Topcare Clearlax Product Label Images

Topcare Clearlax 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 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: •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 •use once a day •use no 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

None

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