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Aleve back and muscle pain - Medication Information

Product NDC Code 0280-6092
Drug Name

Aleve back and muscle pain

Type Brand
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Nonsteroidal Anti-inflammatory Drug [EPC]
Active Ingredients
Naproxen sodium 220 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 849574,
849728
Application Number NDA020204
Labeler Name Bayer HealthCare LLC.
Packages
Package NDC Code Description
0280-6092-02 1 bottle in 1 carton (0280-6092-02) / 130 tablet in 1 bottle
0280-6092-04 1 bottle in 1 carton (0280-6092-04) / 200 tablet in 1 bottle
0280-6092-05 1 bottle in 1 carton (0280-6092-05) / 225 tablet in 1 bottle
0280-6092-08 1 bottle in 1 carton (0280-6092-08) / 250 tablet in 1 bottle
0280-6092-09 1 bottle in 1 carton (0280-6092-09) / 90 tablet in 1 bottle
0280-6092-12 10 tablet in 1 vial (0280-6092-12)
0280-6092-24 1 bottle, plastic in 1 carton (0280-6092-24) / 24 tablet in 1 bottle, plastic
0280-6092-25 1 bottle in 1 carton (0280-6092-25) / 250 tablet in 1 bottle
0280-6092-50 1 bottle, plastic in 1 carton (0280-6092-50) / 50 tablet in 1 bottle, plastic
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older take 1 tablets 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 period Children under 12 years ask a doctor
Adults and children 12 years and oldertake 1 tablets every 8 to 12 hours while symptoms lastfor the first dose you may take 2 tablets within the first hourdo not exceed 2 tablets in any 8-to 12-hour perioddo not exceed 3 tablets in a 24-hour period
Children under 12 yearsask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Purpose

Information about the drug product’s indications for use.
Purposes Pain reliever/fever reducer

Spl product data elements

Usually a list of ingredients in a drug product.
Aleve Back and Muscle Pain Naproxen Sodium MAGNESIUM STEARATE TALC TITANIUM DIOXIDE POVIDONE NAPROXEN SODIUM NAPROXEN FD&C BLUE NO. 2 HYPROMELLOSES MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED ALEVE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package label display All Day Strong® Aleve® Back & Muscle Pain naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer Bayer For temporary relief of minor back and muschle aches and pains ACTUAL SIZE Strength to Last 12 Hours 24Tablets Aleve Back and Muscle Pain - 24 Count Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Dist. by : Bayer Healthcare LLC Whippany, NJ 07981

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
In case of overdose, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information each tablet contains: sodium 20 mg store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API