NDC 27854-555 Belmora Flanax

Naproxen Sodium

NDC Product Code 27854-555

NDC CODE: 27854-555

Proprietary Name: Belmora Flanax 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.

  • Naproxen is used to relieve pain from various conditions. 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. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
141
Score: 1

NDC Code Structure

NDC 27854-555-01

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET in 1 BOTTLE

NDC 27854-555-02

Package Description: 40 PACKET in 1 BOX > 1 TABLET in 1 PACKET

NDC Product Information

Belmora Flanax with NDC 27854-555 is a a human over the counter drug product labeled by Belmora Llc. The generic name of Belmora Flanax is naproxen sodium. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Belmora Llc

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

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.

Belmora Flanax 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 SODIUM 220 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.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

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: Belmora Llc
Labeler Code: 27854
FDA Application Number: ANDA090545 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: 07-20-2020 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: 12-31-2021 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

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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Belmora Flanax Product Label Images

Belmora Flanax 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

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

Purpose

Pain reliever/fever reducer

Uses

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

Other

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 thinner (anticoagulant) or steroid drug■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,

naproxen or others)
■ have 3 or more alcoholic drinks every day while using this product■ take more or for a longer time than directed

Heart attack and stroke warning: NSAID, 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

Otc - Do Not Use

Do not use■ if you ever have had an allergic reaction to any other pain reliever/fever reducer■ right before or after heart surgery

Otc - Ask Doctor

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 stroke■ you are taking a diuretic■ you have problems or serious side effects from taking pain relievers or fever reducers

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are■ under a doctor’s care for any serious condition■ taking any other drug

Otc - When Using

When using this product■ take with food or milk if stomach upset occurs

Otc - Stop Use

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 better■ you have symptoms of heart problems or stroke:■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling■ pain gets worse or lasts for more than 10 days■ fever gets worse or lasts for more than 3 days■ you have difficulty swallowing■ it feels like the pill is stuck in your throat■ redness or swelling is present in the painful area■ any new symptoms appear

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

■ do not take more than directed■ the smallest effective dose should be used■ drink a full glass of water with each doseAdults and children: (12 years and older) ■ take 1 tablet 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 periodChildren under 12 years: ■ ask a doctor

Other Information


each tablet contains: sodium 20 mg
■ store at 68-77ºF (20-25ºC)■ avoid high humidity and excessive heat above 104ºF (40ºC)■ tamper evident sealed packets■ do not use any open or torn packets

Inactive Ingredients

Colloidal silican dioxide, croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

* Please review the disclaimer below.