NDC 59726-751 Naproxen Sodium

Naproxen Sodium

NDC Product Code 59726-751

NDC CODE: 59726-751

Proprietary Name: Naproxen Sodium 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: Naproxen Sodium 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.

  • See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
NP220
Score: 1

NDC Code Structure

  • 59726 - P & L Development, Llc

NDC 59726-751-20

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 20 CAPSULE in 1 BOTTLE, PLASTIC

NDC Product Information

Naproxen Sodium with NDC 59726-751 is a a human over the counter drug product labeled by P & L Development, Llc. The generic name of Naproxen Sodium is naproxen sodium. The product's dosage form is capsule and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1112231.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Naproxen Sodium 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)

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: P & L Development, Llc
Labeler Code: 59726
FDA Application Number: ANDA202807 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: 12-04-2020 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.

Naproxen Sodium 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 Capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • Minor pain of arthritis
  • Toothache
  • Backache
  • The common cold
  • Menstrual crampstemporarily reduces fever

Warnings

  • Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hives facial swelling asthma (wheezing) shock skin reddening rash blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this producttake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducer
  • Right before or after heart surgery

Ask A Doctor Before Use If

  • The stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou have problems or serious side effects from taking pain relievers or fever reducersyou are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor’s care for any serious conditiontaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug

When Using This Product

Take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:
  • Feel faint have bloody or black stools vomit blood have stomach pain that does not get betteryou have symptoms of heart problem or stroke:
  • Chest painslurred speechleg swellingtrouble breathingweakness in one part or side of the bodypain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appearyou have difficulty swallowing it feels like the pill is stuck in your throat

If Pregnant Or Breast-Feeding,

Ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 the smallest effective dose should be useddrink a full glass of water with each dose if taken with food, this product may taken longer to work adults and children 12 years and older:
  • Take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor

Other Information

  • Each tablet contains: sodium 20 mg store at 20º to 25°C (68º to 77°F), excursions permitted between 15ºC and 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature]. Avoid high humidity and excessive heat above 40°C (104°F). Protect from light. read all direction and warnings before use. Keep carton.swallow whole: do not crush, chew or dissolve

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, polyethylene glycol, sorbitan, sorbitol, white pharmaceutical ink

Package Label

READYinCASE All Day Pain Relief Capsules

* Please review the disclaimer below.