NDC 49035-762 Naproxen Sodium

NDC Product Code 49035-762

NDC CODE: 49035-762

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.

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):
12 MM
Imprint(s):
220
Score: 1

NDC Code Structure

NDC 49035-762-10

Package Description: 100 TABLET in 1 BOTTLE

NDC 49035-762-21

Package Description: 225 TABLET in 1 BOTTLE

NDC 49035-762-24

Package Description: 24 TABLET in 1 BOTTLE

NDC 49035-762-30

Package Description: 300 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Naproxen Sodium with NDC 49035-762 is a product labeled by Wal-mart Stores, Inc.,. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 849574.

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.

  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POVIDONE K30 (UNII: U725QWY32X)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wal-mart Stores, Inc.,
Labeler Code: 49035
Start Marketing Date: 05-25-2016 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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

Naproxen

Naproxen is pronounced as (na prox' en)

Why is naproxen medication prescribed?
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints),...
[Read More]

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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 caplet)

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

Purpose

Pain Reliever/Fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:■ minor pain of arthritis■ muscular aches■ backache■ menstrual cramps■ headache■ toothache■ the 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

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

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

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 occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding■ feel faint■ vomit blood■ have bloody or black stools■ have stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysyou have difficulty swallowingit feels like the pill is stuck in your throatredness or swelling is present in the painful areaany new symptoms appear

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 The 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 doseadults and children 12 years and older,■ take 1 caplet every 8 to 12 hours while symptoms last■ for the first dose you may take 2 caplets within the first hour■ do not exceed 2 caplets in any 8- to 12- hour period■ do not exceed 3 caplets in a 24- hour periodchildren under 12 years,■ ask a doctor

Other Information

  • Each caplet contains: sodium 20 mg
  • Store at 20 - 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide.

* Please review the disclaimer below.