NDC 68001-505 Polyethylene Glycol

Polyethylene Glycol

NDC Product Code 68001-505

NDC 68001-505-55

Package Description: 238 g in 1 BOTTLE

NDC 68001-505-69

Package Description: 510 g in 1 BOTTLE

NDC Product Information

Polyethylene Glycol with NDC 68001-505 is a a human over the counter drug product labeled by Bluepoint Laboratories. The generic name of Polyethylene Glycol is polyethylene glycol. The product's dosage form is powder, for suspension and is administered via oral form.

Dosage Form: Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).

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.

Polyethylene Glycol 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.


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.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Bluepoint Laboratories
Labeler Code: 68001
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: 06-18-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Polyethylene Glycol 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

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 paina sudden change in bowel habits that lasts over 2 weeksirritable bowel syndromeAsk a doctor or pharmacist before use if you are taking a prescription drugWhen 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 diarrheayou need to use a laxative for longer than 1 weekIf pregnant or breast-feeding, ask a health professional before use.

Keep Out Of The 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 doctorthe bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line.adults 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 ounces of beverage (cold, hot or room temperature) then drinkensure that the powder is fully dissolved before drinkingdo not drink if there are any lumpsuse once a dayuse no more than 7 dayschildren 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredients

None

* Please review the disclaimer below.