NDC 67091-306 Easylax

Polyethylene Glycol

NDC Product Code 67091-306

NDC Product Information

Easylax with NDC 67091-306 is a a human over the counter drug product labeled by Winco Foods, Llc. The generic name of Easylax is polyethylene glycol. The product's dosage form is powder and is administered via topical form.

Labeler Name: Winco Foods, Llc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Easylax 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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Winco Foods, Llc
Labeler Code: 67091
FDA Application Number: ANDA091077 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: 08-31-2016 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: 12-31-2019 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.

Easylax 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

Uses

  • 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, vomitting 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 (1-800-222-1222) right away.

Directions

  • Do not take more than directed unless advised by your doctorthe bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated lineadults and children 17 years of age and older:
  • Fill to top of line in cap which is marked to indicate the correct dose (17 g)stir and dissolve in any 4 to 8 ounce of beverage (cold, hot, or room temperature) then drink use once a dayuse no more than 7 dayschildren 16 years of age or under: ask a doctor

Other Information

  • Store at 20-25ºC (68-77ºF)

Inactive Ingredient

None

Package Label

WinCo Foods EasyLax Original Prescription Strength

* Please review the disclaimer below.

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