NDC 51824-071 Careall Naproxen

Naproxen Sodium

NDC Product Code 51824-071

NDC Product Information

Careall Naproxen with NDC 51824-071 is a a human over the counter drug product labeled by New World Imports, Inc.. The generic name of Careall Naproxen is naproxen sodium. The product's dosage form is tablet and is administered via oral form.

Labeler Name: New World Imports, Inc.

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.

Careall 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 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE (UNII: FZ989GH94E)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TALC (UNII: 7SEV7J4R1U)

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: New World Imports, Inc.
Labeler Code: 51824
FDA Application Number: ANDA079096 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: 01-14-2019 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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Careall Naproxen Product Label Images

Careall 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

Active Ingredients (In Each Caplet)

Active ingredient (in each caplet)Naproxen sodium 220mg(Naproxen 200mg) (NSAID)**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Uses

Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily 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, blisters. If an allergic reaction occurs, stop use and seek medical help right awayStomach bleeding warning: This product contains NSAID, which may casue 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, take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks everyday while using this product, take more or for a longer time than directed.Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist 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

Do Not Use

Do not use: If you have ever had an allergic reaction to any other pain reliever/fever reducer. Right before or after heart surgery

When Using This Product

When using this product:Take with food or milk if stomach upset occurs.

Ask A Doctor

Ask a doctor before use if:The stomach bleeding warning applies to youYou ahve 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 reducersAsk a doctor or pharmacist before use if you are:Under a doctor's care for any serious conditionTaking any other drugs

Stop Use And Ask A Doctor

Stop use and ask a doctor if:You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy or black stools, have stomach pain that does not get betterYou have symptoms of heart problems or stroke, chest pain, trouble breathing, weakness in one part or side of body, slurred speech, or leg swellingPain gets worse or lasts more than 10 daysFever gets worse or lasts more than 3 days You 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

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 definately 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

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

  • 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 caplet every 8 to 12 hours while symptoms lastFor the first dose you may take 2 caplets within the first hourDo not exceed 2 caplets in any 8 - 12 hour periodDo not exceed 3 caplets in a 24 hour periodChildren under 12 years: ask a doctor

Inactive Ingredients

Croscarmellose sodium, FD&C blue number 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

* Please review the disclaimer below.

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