NDC 41250-225 Naproxen Sodium

Naproxen Sodium

NDC Product Code 41250-225

NDC Code: 41250-225

Proprietary Name: Naproxen Sodium 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: Naproxen Sodium 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.


Product Characteristics
Color(s):
BLUE (C48333 - BLUE WITH WHITE TEXT)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
NP1
Score: 1

Code Structure
  • 41250 - Meijer Distribution Inc
    • 41250-225 - Naproxen Sodium

NDC 41250-225-15

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

NDC 41250-225-78

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

NDC Product Information

Naproxen Sodium with NDC 41250-225 is a a human over the counter drug product labeled by Meijer Distribution Inc. The generic name of Naproxen Sodium is naproxen sodium. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Meijer Distribution Inc

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.


Naproxen Sodium 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.

  • NAPROXEN SODIUM 220 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • MANNITOL (UNII: 3OWL53L36A)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)

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: Meijer Distribution Inc
Labeler Code: 41250
FDA Application Number: NDA021920 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: NDA - A product marketed under an approved 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: 02-01-2019 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.

Naproxen Sodium Product Label Images

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

Other

Drug Facts

***This products is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark ALEVE®.DIST. MEIJER DISTRIBUTION, INC.GRAND RAPIDS, MI 49544www.meijer.comR1118

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: minor pain of arthritismuscular achesbackachemenstrual crampsheadachetoothachethe common coldtemporarily reduces fever

Allergy Alert

  • Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed

Heart 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 reducerright before or after heart surgery

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diureticyou have problems or serious side effects from taking pain relievers or fever reducers

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor's care for any serious conditiontaking 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appearyou have difficulty swallowingit feels like the capsule is stuck in your throat

Otc - Pregnancy Or Breast Feeding

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.

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 directedthe smallest effective dose should be useddrink a full glass of water with each doseif taken with food, this product may take longer to workadults and children 12 years and older:take 1 capsule every 8 to 12 hours while symptoms lastfor the first dose you may take 2 capsules within the first hourdo not exceed 2 capsules in any 8- to 12-hour perioddo not exceed 3 capsules in a 24-hour periodchildren under 12 years:ask a doctor

Other Information

  • Each capsule contains: sodium 20 mgstore at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)read all directions and warnings before use. Keep carton.

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

* Please review the disclaimer below.

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