NDC 49348-143 Clearlax

Polyethylene Glycol 3350

  1. Labeler Index
  2. Strategic Sourcing Services Llc
  3. NDC: 49348-143 Clearlax

NDC Product Code 49348-143

NDC CODE: 49348-143

Proprietary Name: 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.)

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

NDC 49348-143-70

Package Description: 238 g in 1 BOTTLE

NDC 49348-143-92

Package Description: 510 g in 1 BOTTLE

NDC Product Information

Clearlax with NDC 49348-143 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Clearlax is polyethylene glycol 3350. The product's dosage form is powder, for solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 876193 and 880407.

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.

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.

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: Strategic Sourcing Services Llc
Labeler Code: 49348
FDA Application Number: ANDA090812 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: 07-01-2016 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: 12-31-2022 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".

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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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Clearlax Product Label Images

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 grams (cap filled to the indicated “17 GRAMS” line)

Purpose

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, 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 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 diarrheayou need to use a laxative for longer than 1 weekIf 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 doctorthe bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” lineadults and children 17 years of age and older:
  • Fill to indicated “17 GRAMS” line in cap 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 foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive Ingredients

None

For Serious Adverse Events Call:

1-888-710-0006

Package Label

Sunmarkcompare to miralax​ active ingredient*NDC 49348-143-92clearlaxpolyethylene glycol 3350

powder for solution, osmotic laxative
relieves occasional constipation /irregularitySoftens stool grit freeunflavored powdergluten free30 once-daily doses

net wt 17.9 oz (510 g)

* Please review the disclaimer below.