NDC 51991-961 Polyethylene Glycol 3350

Polyethylene Glycol 3350

NDC Product Code 51991-961

NDC Code: 51991-961

Proprietary Name: Polyethylene Glycol 3350 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 51991 - Breeckenridge Pharmaceutical, Inc.
    • 51991-961 - Polyethylene Glycol 3350

NDC 51991-961-58

Package Description: 238 g in 1 BOTTLE

NDC Product Information

Polyethylene Glycol 3350 with NDC 51991-961 is a a human over the counter drug product labeled by Breeckenridge Pharmaceutical, Inc.. The generic name of Polyethylene Glycol 3350 is polyethylene glycol 3350. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Breeckenridge Pharmaceutical, Inc.

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 Additional informationCallout TooltipWhat 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 3350 Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Breeckenridge Pharmaceutical, Inc.
Labeler Code: 51991
FDA Application Number: ANDA090812 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-27-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Polyethylene Glycol 3350 Product Label Images

Polyethylene Glycol 3350 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

Other

Drug Facts

Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Distributed by:Breckenridge Pharmaceutical, Inc.Boca Raton, FL 33487

Active Ingredient (In Each Dose)

Polyethylene Glycol 3350, 17 grams (cup filled to the indicated "17 GRAMS" line)

Purpose

Osmotic Laxative

Use

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

Allergy Alert

Do not use if you are allergic to polyethylene glycol

Otc - Do Not Use

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 syndrome

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Otc - When Using

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 diarrheayou need to use a laxative for longer than 1 week

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than directed unless advised by your doctorThis product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.adults and children 17 years of age and older:fill to indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 gramsstir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drinkuse once a dayuse no more than 7 dayschildren 16 years of age or younger: ask a doctor

Other Information

  • Store at 20° - 25°C (68° - 77°F)tamper-evident: do not use if seal under cap printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Inactive Ingredients

None

* Please review the disclaimer below.

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