NDC 70518-2428 Naproxen

Naproxen

NDC Product Code 70518-2428

NDC CODE: 70518-2428

Proprietary Name: Naproxen 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 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):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
140
Score: 2

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2428-0

Package Description: 30 TABLET in 1 BLISTER PACK

NDC Product Information

Naproxen with NDC 70518-2428 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Naproxen is naproxen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription 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 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.

  • NAPROXEN 500 mg/1

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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE (UNII: FZ989GH94E)

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.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Anti-Inflammatory Agents -
  • Non-Steroidal - [CS]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA091416 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: 11-18-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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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 Product Label Images

Naproxen 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

Med Guide For Naproxen Tablets Usp 250 Mg 375 Mg 500 Mg

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?




NSAIDs can cause serious side effects, including:



Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:o with increasing doses of NSAIDs




o with longer use of NSAIDs




Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”




Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.



Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:o any time during use




o without warning symptoms




o that may cause death




The risk of getting an ulcer or bleeding increases with:




o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs




o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”




o increasing doses of NSAIDs o older age




o longer use of NSAIDs o poor health




o smoking o advanced liver disease




o drinking alcohol o bleeding problems




NSAIDs should only be used:




o exactly as prescribed




o at the lowest dose possible for your treatment




o for the shortest time needed



What are NSAIDs?




NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.



Who should not take NSAIDs?




Do not take NSAIDs:




• if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.




• right before or after heart bypass surgery.



Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:




• have liver or kidney problems




• have high blood pressure




• have asthma




• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.




• are breastfeeding or plan to breastfeed.




Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.



What are the possible side effects of NSAIDs?




NSAIDs can cause serious side effects, including:




See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)"?




• new or worse high blood pressure




• heart failure




• liver problems including liver failure




• kidney problems including kidney failure




• low red blood cells (anemia)




• life-threatening skin reactions




• life-threatening allergic reactions




• Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.




Get emergency help right away if you have any of the following symptoms:



shortness of breath or trouble breathing




chest pain




weakness in one part or side of your body




slurred speech




swelling of the face or throat



Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:nausea




more tired or weaker than usual




diarrhea




itching




your skin or eyes look yellow




indigestion or stomach pain




flu-like symptoms




vomit blood




there is blood in your bowel movement or it is black and sticky like tar




unusual weight gain




skin rash or blisters with fever




swelling of the arms and legs, hands and feet



If you take too much of your NSAID, call your healthcare provider or get medical help right away.




These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to Marksans at 1-877-376-4271 and/orFDA at 1-800-FDA-1088.



Other information about NSAIDsAspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.




Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.



General information about the safe and effective use of NSAIDs




Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.




If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.



Manufactured for:




Time-Cap Labs, Inc.




7 Michael Avenue,




Farmingdale,




NY 11735, USA




Manufactured by:




Marksans Pharma Ltd.




Plot No. L-82, L-83,




Verna Indl. Estate,




Verna, GOA - 403722, India.



This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: October 2017

* Please review the disclaimer below.