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| Product NDC Code | 0280-6070 | ||||
|---|---|---|---|---|---|
| Drug Name | Aleve gelcaps |
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| Type | Brand | ||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, COATED | ||||
| RxCUI drug identifier | 849574, 849728 |
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| Application Number | NDA020204 | ||||
| Labeler Name | Bayer HealthCare LLC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 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 period Children under 12 years ask a doctor
| Adults and children 12 years and older |
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| Children under 12 years |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, 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: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Aleve Gelcaps NAPROXEN SODIUM ALUMINUM OXIDE D&C YELLOW NO. 10 EDETATE DISODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GELATIN GLYCERIN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE STEARIC ACID TALC TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN 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.PRINCIPAL DISPLAY PANEL SOFT GRIP® ARTHRITIS CAP ALL DAY STRONG® ALEVE® naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer THIS PACKAGE IS CHILD-RESISTANT STRENGTH TO LAST 12 HOURS 40 GELCAPS GELATIN COATED CAPSULE-SHAPED TABLETS Aleve Gelcaps - 40 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
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)
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
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